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Learn more about the centers and cores at the Pittsburgh Heart, Lung, Blood, and Vascular Medicine Institute and how our multidisciplinary team of scientists is advancing research in the heart, lung, and blood systems.

In the News

Dr. Catalin Toma served as the local principal investigator on a study of stem-cell therapy for heart failure treatment. Results were recently published and presented at the annual meeting of the American College of Cardiology.

Read more.

Heart and Vascular Clinical Trials

Clinical trials are research studies involving human volunteers who are closely monitored by:

  • Doctors
  • Nurses
  • Research assistants
  • Data analysts

If you are considering participation in a clinical trial, it is important to:

  • Discuss your health and review your medical records with your cardiologist and care team to determine eligibility.
  • Ask your cardiologist to assist you in discussing the decision with family members and caregivers, so questions or concerns can be addressed.
  • Work with your doctor to sign and consent to trial treatment.
  • Remember that participation is voluntary. You may choose to or be asked to cease participation in the trial at any time.

Learn more about the University of Pittsburgh's Research Participant Registry.

Search the US government's clinical trial database now for heart and vascular trials.

Featured Clinical Trials and Research

SeCure: A Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser
Treatment (EVLT) 400 μm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins
Sponsored by: AngioDynamics

​Who can participate

Patients with advanced venous disease

​What we'll study

​Incompetent perforating veins (IPVs) are a common cause of venous hypertension and non-healing venous ulcers of the legs. The objective of this study is to assess the Angiodynamics 400 μm fiber for ablation of incompetent perforating veins in patients with advanced venous disease. This includes skin discoloration, ulcer or healed ulcer. The goal of this procedure is to stop flow in dysfunctional perforating veins and decrease venous pressure.

The study will be performed by the UPMC Department of Vascular Surgery at the following three outpatient locations:

  • Magee-Womens Hospital of UPMC
  • UPMC Shadyside
  • UPMC St. Margaret

Patients over 18 years of age with severe symptomatic venous disease (CEAP class 4b-6) and absence of saphenous reflux are eligible for study screening. Patients must be ambulatory and willing to consent to the trial. Patients will undergo a specialized duplex exam to determine anatomic suitability. Patients with venous obstruction due to past or recent deep vein thrombosis (DVT) may be ineligible for the study based on the location and extent of the previous clot. Patients currently on anticoagulation medicines or with a body-mass index (BMI) over 40 are not eligible for the study.

Participants are chosen based on a diagnosis of an incomplete perforator vein and meet the inclusion/exclusion criteria. Participants who meet the eligibility criteria will be consented for participation in the trial and screened. Screening includes a complete medical and surgical history assessment complemented by duplex ultrasonography (DUS) scanning of the entire study limb. In addition, vein mapping, CEAP score classification, and rVCSS scoring will be assessed prior to and after treatment.

All participants must be able to meet all of the follow up requirements to be enrolled for this study. All subjects that qualify must agree to and be willing to be evaluated at 10 days, 1, 3, 6, 9 and 12 months post procedure.

​Compensation

​**Please note: Once enrolled in this study, participants will receive at no charge: Doppler ultrasound(s), vein mapping, EVLT procedures, and pregnancy testing (when applicable). All other aspects of the study will be billed to participants insurance as “standard of care.”

​Who to contact

 To learn more about this study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu.

Research Study for Clinical Implications of Genetic Variations of Venous Stasis Ulcerations

​Who can participate

​Patients found to have venous stasis ulcers, healed venous ulcers, and/or patients 50 or older without venous disease

​What we'll study

​The primary objective of this research study is to determine if there is a genetic link between venous stasis ulcers, stratify subjects according to their potential to heal, and guide levels of therapeutic interventions and preventative strategies.

This study is focusing on the following three classifications:

  • Group 1: active venous stasis (CEAP 6)
  • Group 2: healed venous stasis ulcer (CEAP 5)
  • Group 3: normal controls without venous disease (CEAP class 0 or 1)

Note: CEAP classification (Clinical, Etiologic, Anatomic, Pathophysiologic) is a tool that is used to determine the degree of venous insufficiency

​How we'll conduct the study

​The research study will be performed by the UPMC Division of Vascular Surgery at the following five outpatient locations:

  • Magee-Womens Hospital of UPMC
  • UPMC Mercy
  • UPMC Passavant
  • UPMC Shadyside
  • UPMC St. Margaret

Participants will be chosen based on a diagnosis of venous ulcers (18 or older), healed venous ulcers (18 or older), or controls without venous disease (age 50 or older) that meet the inclusion criteria and none of the exclusion criteria. All subjects will undergo genetic profiling based on a single blood test that will be performed at the time of consent. If any abnormalities are identified on the blood test, we will notify your primary care physician.

Follow-up

Group 1 (CEAP Class 6): After consent, all participants will receive monthly follow-up as per routine clinical care to check on their wounds. No additional or extra follow-up is required for this study.

Group 2 (CEAP Class 5): After consent, all participants will receive follow-up at six months as per routine clinical care to check on their wounds. No additional or extra follow-up is required for this study.

Group 3: (CEAP 0 or 1): After consent, all participants will take part in a one-time visit. At the completion of this visit, the participant will receive a $5.00 meal ticket that can be redeemed at the hospital cafeteria in which the evaluation was performed, and validation of their parking ticket. In addition, each participant in group 3 will have a Doppler ultrasound of their lower extremities at no cost to evaluate for venous insufficiency/reflux. No additional follow-up is needed.

Please note: there is no additional compensation for participation in this study

​Who to contact

To learn more about this research study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu.

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of
Proximal Descending Thoracic Aortic Aneurysms (SSB 11-02, investigational device)

Who can participate Patients with thoracic aortic aneurysms
What we'll study

The SSB 11-02 device treats thoracic aortic aneurysms, which generally occur in the elderly and can lead to a life-threatening rupture of the aorta, the largest artery in the body. Designed to seal-off a hard-to-treat section of the aorta, the device potentially provides a safe and less invasive alternative to open heart surgery.

Through thoracic branch technology and design, this device fits the unique characteristics of the descending aorta, allowing physicians to treat a subset of patients that could not be considered for total endovascular repair in the past.

Endovascular repair uses real-time x-ray and guidewires to help deliver a graft, inserted via catheter, to exclude the lesion inside the diseased aorta, making a new path for blood to flow. Through this less invasive technique, physicians can treat conditions through small incisions in the groin that might otherwise require open chest surgery.

It is hoped that the utilization of this device will reduce the need for invasive surgical procedures commonly required today, thus reducing the complications associated with treatment of this complex disease.

Who to contact To learn more about this study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu

A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular
Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions

​Who can participate Patients may be eligible to participate in this research study if they have been determined or suspected to have coronary (heart) arteries (blood vessels) with significant narrowing or blockages that require treatment with a coronary artery stent.
​What we'll study ​This study will further assess the safety, effectiveness, and the potential short and long-term benefits of treating blockages in the coronary arteries with an investigational (experimental) device called Absorb™ Bioresorbable Vascular Scaffold (BVS) System, compared to a commercially FDA-approved metallic stent (Xience) coated with medication (drug-eluting stent).

 

The Absorb BVS is a temporary device which functions like a drug-eluting stent, but is not made out of metal. Instead it consists of a plastic scaffold (which helps keep the artery open) made out of materials called polylactide polymers and copolymers. Over time these materials will gradually break down and be resorbed into the artery wall leaving behind no permanent implant.

The Absorb BVS is investigational and has not been approved for use in the heart artery, but is approved by the FDA for use in this study.

Patients will be randomized to receive either the Absorb BVS or XIENCE. Randomization is a process that assigns you to the treatment by chance, rather than by choice, to either the Absorb BVS treatment or the XIENCE treatment.

The study is single-blind, which means if you are randomized, you will not be told which device you have received. This prevents the knowledge or expectations from influencing the results of the study. The study doctor and study staff who are present at the procedure will know which device you receive, but will not tell you until all subjects in the study have completed their five-year follow up visit, which may be potentially in six or seven years.

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact Laurie Dennis, RN, Clinical Research Supervisor at 412-647-6210 or Catalin Toma, MD at 412-647-0211.

PARACHUTE IV (PercutAneous Ventricular RestorAtion in Chronic Heart FailUre due to
Ischemic HearT DiseasE)

​Who can participate

​Patients may be eligible to participate in this research study if they have been diagnosed with heart failure due to a previous heart attack.

​What we'll study

​This study will evaluate the safety and effectiveness of the CKI Parachute implant in the treatment of patients with heart failure due to ischemic heart disease.

This study is focusing on the following three classifications:

The study device is an investigational device and is not approved for use by the U.S. Food and Drug Administration.

​How we'll conduct the study

​Your participation in the study first involves undergoing a comprehensive screening process including cardiac exam, assessment of heart failure (NYHA) class, transthoracic echocardiogram (TTE), and cardiac computed tomography (CT). If you are determined to be eligible to participate, then you will be randomly assigned to either receive the Parachute Implant or not. Half of the subjects enrolled into the study will receive the Parachute Implant (treatment group) and half will not (those subjects will be part of the “control” group). All randomized subjects will have a six month and annual follow-up visits to the study doctor out through five years.

If you are in the treatment group your participation in the study would involve undergoing a procedure called a heart catheterization, during which a catheter (a small, hollow tube) is inserted into a blood vessel in your groin and advanced into your heart so that the study device can be placed in your left ventricle.

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact Laurie Dennis, RN, Clinical Research Supervisor at 412-647-6210 or Catalin Toma, MD at 412-647-0211.

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of
Aortic Arch Aneurysm (SSB 11-03)
Sponsored by: W.L. GORE and Associates

​Who can participate ​Patients with Aortic Arch Aneurysm (saccular or fusiform >5.5cm)
​What we'll study ​An aortic aneurysm is caused by a weakening in the wall of the aorta. One of the accepted treatments is to place a tube (called a stent graft) inside the aneurysm via an artery in the groin. Once the stent graft is in place, the blood will flow through the stent graft instead of against the weakened part of the aorta. The stent graft stays there permanently.

 

The study will be performed by the Department of Vascular Surgery at UPMC Shadyside. Patients follow up can be done at these locations:

  • UPMC Shadyside
  • UPMC Passavant

Patients over 18 years of age with an aortic arch aneurysm of 5.5cm, or 2 times the native diameter, or a saccular aneurysm. Participants are chosen based on a diagnosis of aortic arch aneurysm and meet the inclusion/exclusion criteria. Participants who meet the eligibility criteria will be consented for participation in the trial and screened. Screening includes a complete medical and surgical history assessment complemented by a CT scan and required blood work. Once the CT scan has been reviewed by your physician and the sponsor and both agree you are a candidate for this device, surgery can be scheduled. It is a two-part surgery; first, one or two of the major branch vessels off of the aorta are rerouted. Then, the stent graft stent graft is placed in the aortic arch and one branch vessel to exclude any more blood flow to the aneurysm but retain blood flow to the rest of the body.

All participants must be able to meet all of the follow up requirements to be enrolled for this study. All subjects that qualify agree to and will be evaluated at one, 24, 36, 48, and 60 months. Evaluations include a CT scan and pressure assessments. You will also be required to obtain a Creatinine blood level at each visit.

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu.

Use of the Zenith® Dissection Endovascular System in the Treatment of Patients with
Acute, Complicated Type B Aortic Dissection (STABLE II)

​Who can participate Patients who have been diagnosed with a dissection in your thoracic (chest) aorta.
​What we'll study

​The STABLE II clinical trial is a prospective, multi-center, controlled clinical study, designed to evaluate the safety and effectiveness of the endovascular treatment, using the Zenith® TX2® Dissection Endovascular Graft and Zenith® Dissection Endovascular Stent. Your healthcare institution is involved with other hospitals in a study evaluating the endovascular method for placing a graft to treat thoracic dissections. The trial will include approximately 103 subjects at up to 30 investigational sites.

A dissection is a longitudinal (length-wise) tear in the wall of the aorta that usually occurs as a result of high blood pressure. While some dissections require immediate open surgery other types of dissections may be treated with medical management or endovascular treatment.

If you receive the endovascular treatment, a graft will be placed through your arteries and into your aorta. To do this, incisions will be made in your groin area. An incision may be made in your arm as well to assist with the procedure. X-rays will be used to guide the graft to your aorta. You will receive injections of a fluid (called contrast medium), which allows the study doctor to better see your blood vessels. After placement of the graft, your groin and arm incisions will be closed.

You may be eligible if:

  • You are 18 years of age or older
  • You have been diagnosed with a dissection in your thoracic (chest) aorta.
  • Your doctor has determined that you are eligible to be in the study by measurements of your aorta

Your participation in this study will begin when you sign the informed consent form and once the procedure has begun (cutdown or percutaneous access initiated) and continue for up to five years following your endovascular procedure. During this time, we will ask you to come to 8 visits at UPMC, which includes the procedure involving the investigational stent and graft. After the procedure, you will be admitted to the hospital for typically 3 to 7 days. You may also be contacted by telephone in between your study visits to see how you are doing.

The study will be performed UPMC Heart and Vascular Institute at the following outpatient location:

  • UPMC Shadyside
​Compensation

You will not be paid to take part in this study.

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the UPMC Heart and Vascular Institute at 1-84-HVI-TRIAL (844-848-7425) or email HVIresearch@upmc.edu. More information can also be found here, under trial # NCT01568320.

Portico Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO IDE)

​Who can participate Patients with severe aortic valve stenosis who are not good candidates for surgical replacement are eligible for screening by their physician for a Portico valve.
​What we'll study

​The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico). The trial will include approximately 1206 randomized subjects at up to 60 investigational sites. Additionally up to 100 subjects may be enrolled in a Valve-in-Valve registry.

Aortic stenosis is a condition in which the aortic valve is narrowed and does not open normally. Calcium in the blood can build up on the valve, causing a hardening of the valve. When the aortic valve becomes constricted, the ability of the left ventricle to pump blood out of the heart to the aorta and other arteries in the body is impaired. Sometimes blood may back up into your lungs causing shortness of breath.

The study valve is made to replace your diseased aortic heart valve. We also want to find out if the St. Jude Medical Portico Transcatheter Heart Valve is safe and equal to valves already on the market.

You may be eligible if:

  • You are 21 years of age or older
  • You have severe, symptomatic aortic stenosis
  • Your doctor has determined you to be at high or extreme operative risk for surgical aortic valve replacement

Your participation in this study will begin when you sign the informed consent form and continue for up to five years following your implant. During this time, we will ask you to come to nine visits at UPMC, which includes the procedure to implant the investigational heart valve device. After the implant, you will be admitted to the hospital for two to six days. You may also be contacted by telephone in between your study visits to see how you are doing.

The study will be performed UPMC Heart and Vascular Institute at the following three outpatient locations:

  • UPMC Presbyterian
  • UPMC University Center
  • UPMC Shadyside
​Compensation

You will not be paid to take part in this study. You will receive a stipend in the amount of $25.00 to cover the cost of travel and parking for each required research-related visits. There are a total of eight required visits (baseline, 30 day, six month, 12 month, second year, third year, fourth year, and fifth year).

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the UPMC Heart and Vascular Institute at 1-84-HVI-TRIAL (844-848-7425) or email HVIresearch@upmc.edu. More information can also be found here, under trial # NCT02000115.

CytoSorb® Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH Trial)

​Who can participate Subjects undergoing cardiac surgery requiring CPB with an anticipated length of CPB greater than or equal to 3 hours are eligible.
​What we'll study

​The REFRESH clinical trial is a prospective, multi-center, randomized, feasibility clinical study; it is designed to evaluate the safety and performance of the investigational CytoSorb® device to reduce plasma free hemoglobin when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery. The study will include approximately 56 subjects who will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.

Hemolysis and the release of plasma free hemoglobin (PfHb) that occurs during CPB has been directly correlated with prolonged ICU stay, induction of endothelial, tissue, and organ injury, as well as inflammation. Plasma free hemoglobin is thought to be a significant contributor in the development of multiple organ dysfunction and failure in patients following cardiac surgery.

You may be eligible if:

  • 18-80 years of age
  • Surgery is an elective, non-emergency procedure
  • Cardiac surgery other than primary coronary artery bypass grafting, single valve procedure, cardiac transplant, or ventricular assist device explant, requiring CPB with anticipated duration of CPB greater than or equal to 3 hours

Your participation in this study will begin when you sign the informed consent form and continue for up to 30 days post-operative. During this time, research coordinators will be extracting data from your medical records as well as coordinate blood and urine samples during pre-procedure, procedure, and post procedure while in the ICU. You will also receive a phone call at 30 days post procedure.

The study will be performed at UPMC Shadyside by part of the UPMC Heart and Vascular Institute.

​Compensation

You will not be paid to take part in this study.

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the UPMC Heart and Vascular Institute at 1-84-HVI-TRIAL (844-848-7425) or email HVIresearch@upmc.edu. More information can also be found here, under trial # NCT02566525.

Medtronic CoreValve™ SURTAVI Trial SUrgical Replacement and Transcatheter Aortic Valve
Implantation

​Who can participate Patients with severe aortic valve stenosis who are good candidates for surgical replacement and/or transaortic valve replacement.
​What we'll study

​The SURTAVI clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the Medtronic CoreValve system/CoreValve Evolut R system versus standard surgical aortic valve replacement. Aortic stenosis is a condition in which the aortic valve is narrowed and does not open normally. Calcium in the blood can build up on the valve, causing a hardening of the valve. When the aortic valve becomes constricted, the ability of the left ventricle to pump blood out of the heart to the aorta and other arteries in the body is impaired. Sometimes blood may back up into your lungs causing shortness of breath.

The study valve is made to replace your diseased aortic heart valve. We also want to find out if the Medtronic CoreValve System/ CoreValve Evolut R System Valve is safe and effective compared to standard (open heart) surgical valve replacement.

You may be eligible if:

  • You are 21 years of age or older
  • You have severe, symptomatic aortic stenosis
  • Your doctor has determined you to be at moderate operative risk for surgical aortic valve replacement

Once you have signed an informed consent testing will be done to determine if you are a good candidate for the study. Upon successful completion of testing, randomization will occur. Randomization is like a flip of a coin and you will be assigned to either have the investigational transaortic (TAVI) valve or you will be randomized to standard open heart surgery to replace your diseased valve. Your continuation in the study will continue for up to five years following your implant. During this time, we will ask you to come to 9 visits at UPMC, which includes the procedure to implant the heart valve device. After the implant, you will be admitted to the hospital for 2 to 6 days. You may also be contacted by telephone in between your study visits to see how you are doing.

The study will be performed UPMC Heart and Vascular Institute at the following three outpatient locations:

  • UPMC Presbyterian
  • UPMC University Center
  • UPMC Shadyside
​Compensation

You will not be paid to take part in this study. You may be eligible for travel and parking reimbursement. There are a total of 8 required visits (30 day, six month, 12 month, 18 month, second year, third year, fourth year, and fifth year).

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the UPMC Heart and Vascular Institute at 1-84-HVI-TRIAL (844-848-7425) or email HVIresearch@upmc.edu. More information can also be found here, under trial # NCT01586910.

Safety & Efficacy of Intramyocardial Injections of Mesenchymal Precursor
Cells on Myocardial Function in LVAD Recipients

​Who can participate Patients with end-stage heart failure who are being evaluated for LVAD (artificial heart) are eligible for screening by their physician for enrollment into this study.
​What we'll study

​The main purpose of this research is to determine whether injecting 150 million mesenchymal precursor cells (stem cells, MPCs) into the heart during surgery to implant a left ventricular assist device (artificial heart, LVAD) is safe. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.

Patients will be randomized (assigned by chance) to one of two groups. Group 1 will have MPCs called RevascorTM (manufactured by Mesoblast Ltd.) injected into the heart muscle and Group 2 will receive control solution (cell preservative without the cells) injections instead of cells.

MPCs are normally present in human bone marrow, and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. This study will test to see if these effects are enough to improve overall heart function. The stem cells being tested in this study are obtained from healthy human donors and are grown in the laboratory. This study will compare the heart function of patients who receive injection of one dose of the ResvascorTM cells to patients who receive injection of a control solution (cell preservative without the cells) at the time of LVAD implantation surgery.

​Compensation

You will not be paid to take part in this study. There are a total of 9 required visits (baseline, 30 day, 60 day, 90 day, 4 month, 6 month, 9 month, 12 month, and 24 month timepoints). You will be asked to continue in this study until 24 months following LVAD implantation or until you receive your heart transplant (if you are a bridge to transplant patient), whichever comes first. Your participation in this study will not prevent or delay you from getting your heart transplant surgery (if you are a bridge to transplant patient).

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the UPMC Heart and Vascular Institute at 1-84-HVI-TRIAL (844-848-7425) or email HVIresearch@upmc.edu. More information can also be found here, under trial # NCT02362646.

 

 

 

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