AID MI Study
PI: Samir Saba, MD
Research Coordinator: Donna Simpson, RN
The purpose of this research study is to determine and understand the clinical outcomes in patients following an AMI with cardiac monitoring using the Confirm RX Insertable Cardiac Monitor or Abbott equivalent commercially available insertable cardiac monitor. Your involvement in the trial will be for two years following randomization and the trial will enroll approximately 200 patients.
- Follow-up will be done at 30 days, 90 days, 12 months, and 24 months after enrollment. All follow-up visits could be performed remotely by phone call and remote device interrogation (if applicable) or in person at the outpatient clinic.
- Questionnaires and surveys will be completed by the patient during the follow-up period.
- There will be two treatment groups randomly assigned. 100 patients will be assigned to a control group (no device) and the other 100 patients will be assigned to receive the Insertable Cardiac Monitor.
Reach out to Donna, RN (UPMC Lead Site Coordinator) at (412) 647-4463 or simpsondm@upmc.edu or Eric, RN at (412) 647-8210 or pasquantonioej@upmc.edu for more details.
Avier DR i2i Study
PI: Sandeep Jain, MD
Research Coordinator: Liz Benckart
The Aveir™ DR i2i Study will evaluate the Aveir™ Dual-chamber Leadless Pacemaker System in patients who require bradycardia (slow heartbeat) pacing therapy to monitor and manage their heart rate. Participants in the study will play an important role in helping doctors evaluate leadless pacing as an option for people with slow or irregular heart rhythms. You may qualify if:
- You have been diagnosed with symptomatic bradycardia, sinus pauses and/or AV block.
- Your physician has told you that a dual-chamber pacemaker may help your slow or irregular heartbeat.
Reach out to Liz, RN, for details at (412) 647-4463 or by email at benckarte2@upmc.edu.
Catalyst
PI: Samir Saba, MD
Research Coordinator: Susan Sweeny
The CATALYST Trial is studying the Amplatzer™ Amulet™ Left Atrial Appendage Occluder in patients with non-valvular atrial fibrillation who are either on a non-vitamin K antagonist oral anticoagulant (NOAC) blood thinner, or eligible to take a NOAC.
WHO CAN PARTICIPATE IN THE CATALYST TRIAL COMPARING LEFT ATRIAL APPENDAGE OCCLUSION TO NOAC THERAPY? Both men and women can participate.
You may qualify if:
- You have been diagnosed with non-valvular atrial fibrillation and are at an increased risk for ischemic stroke
- Your doctor believes you are eligible for NOAC therapy
- You are willing and able to complete the study follow-up visits
- You are willing to receive an Amulet Left Atrial Appendage Occluder if randomized to that therapy
**We're expecting activation soon. Please reach out to Susan Sweeny, RN, for details at 412-864-1420 or sweenysm@upmc.edu.**
Champion AF
PI: Sandeep Jain, MD
Research Coordinator: Liz Benckart
Currently, WATCHMAN is an FDA approved device alternative for AFib patients who are unable to tolerate long-term blood thinner medication. The CHAMPION-AF Clinical trial is studying WATCHMAN as a first choice option versus blood thinners (NOAC) for AFib patients who may be medically able to tolerate long-term blood thinner use, but would consider a one-time option for stroke risk reduction.
You may be a candidate for the CHAMPION-AF clinical trial if you can answer YES to the following questions:
- I have been diagnosed with non-valvular atrial fibrillation
- I have been deemed suitable for long term-blood thinner therapy
- I would prefer a one-time for a lifetime procedure option that permanently reduces stroke risk
To learn more, contact Liz Benckart at 412-647-4463 or benckarte2@upmc.edu.
We're also offering this study at UPMC in Harrisburg.
PI: Chinmay Patel, MD
Research Coordinator: Dawn Macfarlane
FACT CRT
PI: Andrew Voigt, MD
Research Coordinator: Eric Pasquantonio, RN
The purpose of this study is to validate how data collected using an echocardiogram, a heart imaging study, predicts response to cardiac resynchronization therapy provided by the CRT-D in individuals without the LBBB rhythm, and to identify new variables recorded from electrocardiograms (ECG) or echocardiography to improve use of the implanted device called “cardiac resynchronization therapy” in patients with heart failure.
You are being asked to take part in this study because you have been diagnosed with heart failure (HF) a chronic condition associated with heart muscle weakness and do not have heart arrythmia abnormality called left bundle branch block (LBBB), and you are scheduled to undergo implantation of a cardiac resynchronization therapy device with a defibrillator (CRT-D).
** We are expecting activation soon. Please reach out to Eric Pasquantonio at 412-647-4463 for additional information.**
Optimizer PAS
PI: Sandeep Jain, MD
Research Coordinator: Sherry Pellegin
Do you have Heart Failure? You may be interested in the FDA approved Optimizer Smart, which is a device used to treat heart failure in patients on medical therapy who still have significant symptoms. Optimizer Smart devices are implanted just the way pacemakers/defibrillators are implanted, through a small incision. Participants will be asked to complete the following:
- Study Related testing at no cost to determine eligibility
- 1 clinic visit after implant of the Optimizer Smart System
- Routine checks via phone calls
- One annual in-home visit for 3 years
Ask your doctor about the Optimizer Smart CCM device, and about participating in the Optimizer Smart Post Approval study.
Contact Sherry Pellegrino at 412-647-8437 or pellegrinosl@upmc.edu to learn more.
We're also offering this study at UPMC in Harrisburg.
PIVATAL
PI: Krishna Kancharla, MD; David Kaczorowski, MD
Research Coordinator: Rachel Mcgargle; Susan Sweeny
Looking for patients with advanced cardiomyopathy (INTERMACS classification) and eligible for LVAD per HF clinical team who have had ICD w/remote monitoring in past and sustained VT or VF episode (>30 seconds in duration) in the past 5 years.
Reach out to Rachel, RN 412-864-0788, mcgarglerd@upmc.edu; or Susan, RN 412-864-1420, sweenysm@upmc.edu for more information.
If you have any potential candidates for the study, please contact Susan Sweeny, RN, at 412-864-1420 or sweenysm@upmc.edu.
PVC Imaging
PI: Sandeep Jain, MD
Research Coordinator: Susan Sweeny
The research study is being conducted to evaluate if imaging techniques can identify irregular heart rhythms with extra heart beats (PVCs) that would cause a cardiomyopathy.
The purpose of this study is to find out if we can determine if certain extra heart beats are bad for the heart and could cause the heart function to decline.
You are being invited to participate in a research study because you have an irregular heart rhythm with extra heart beats (PVCs).
***We've currently paused enrollment for this study. It should resume shortly.
If you have any potential candidates for the study, please contact Susan Sweeny, RN, at 412-864-1420 or sweenysm@upmc.edu.
Sync AV
PI: Aditya Bhonsale, MD
Research Coordinator: Sherry Pellegrino
A study of patients to receive a new CRT implant or upgrade (Abbott CRT device and Abbott Quadripolar LV Lead) to an existing ICD/pacemaker implant.
They must not have prior LV lead placement and must have:
- HF
- LVEF ≤ 35%
- LBBB
- Intact AV conduction
The SyncAV post-market trial will study changes in left ventricular end-systolic volume (LVESV) between:
- Baseline (before CRT implant).
- 12 months (post-randomization).
The study will compare patients with CRT devices programmed with SyncAV to those programmed with fixed AV delay.
Contact Sherry Pellegrino at 412-647-8437 or pellegrinosl@upmc.edu.