ADVENT-PAS Study

The ADVENT-PAS study is evaluating the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treating people with paroxysmal atrial fibrillation (AFib), a condition where the heart experiences sudden episodes of irregular and often rapid beating. This procedure uses short bursts of electrical energy to target the specific heart tissue responsible for triggering abnormal rhythms, with the goal of restoring a normal heartbeat while minimizing damage to surrounding tissue. Because the device is already FDA-approved, this post-approval study follows patients over time at multiple medical centers to see how well the treatment works in everyday clinical practice. Researchers are tracking how often AFib returns, monitoring for any side effects or complications, and assessing overall patient outcomes to confirm that the procedure is both safe and consistently effective outside of earlier controlled. This trial’s principal investigator is Raul L. Weiss, MD, FAHA, FACC, FHRS, Director, William E. & Molly Ford Cardiac Electrophysiology Center.

BACKBEAT Trial

The BACKBEAT trial is studying a new way to lower high blood pressure using a pacemaker. Researchers are testing whether a specially programmed pacemaker can safely help people with hard-to-control high blood pressure lower their numbers, in addition to their regular medications. Specifically, doctors are studying a software feature called atrioventricular interval modulation (AVIM) that can be downloaded into a standard dual-chamber pacemaker (a device implanted to help regulate slow heart rhythms) Normally, pacemakers are used to fix slow or irregular heartbeats. In this study, doctors program this special setting into a standard Medtronic pacemaker that slightly changes the timing of the heart’s beats. Researchers are looking to find out if this approach may lower blood pressure safely compared with standard pacemaker use. This trial’s principal investigator is Raul L. Weiss, MD, FAHA, FACC, FHRS, Director, William E. & Molly Ford Cardiac Electrophysiology Center.

COSIRA II Study

The COSIRA II study is looking at a new treatment option for people who have refractory angina, which means they continue to have chest pain from poor blood flow to the heart even after trying standard treatments like medications, stents, or bypass surgery. The study is testing a small, implanted device called the Coronary Sinus Reducer, which is placed in a vein of the heart to help improve blood flow to areas that aren’t getting enough oxygen. The device gently changes the pressure inside the heart’s veins to redirect blood to where it’s needed most. Researchers are studying whether this approach safely reduces chest pain and improves quality of life for patients who have run out of other treatment options. This study’s principal investigator is Nirat Beohar, MD, Director, Cardiac Catheterization Laboratory, Director, Interventional Cardiology Fellowship Program, Medical Director, Structural Heart Disease Program.

PARTNER-3 Study

The PARTNER 3 study looked at a less invasive way to replace a severely narrowed heart valve in patients who were considered low risk for traditional open-heart surgery. It focused on the SAPIEN 3 Transcatheter Heart Valve, a replacement valve that can be inserted through a blood vessel in the leg instead of opening the chest. The study carefully compared this newer procedure to standard surgical valve replacement in patients with severe, calcium buildup–related aortic stenosis (a condition where the heart’s main valve becomes stiff and doesn’t open properly). Because the study was randomized and conducted at many hospitals, it provided strong evidence about how safe and effective the minimally invasive approach is. In simple terms, the research asked: for healthier patients who need their aortic valve replaced, can this less invasive procedure work as well as or better than traditional surgery. This study’s principal investigator is Steve Xydas, Chief of Division of Cardiac Surgery, Co-Director, Mount Sinai Heart Institute, Co-Director, Aortic Center.

TECTONIC CAD IVL Study

The TECTONIC CAD IVL study is researching a newer way to treat blocked heart arteries that have heavy calcium buildup. It focuses on a technology called intravascular lithotripsy (IVL), which uses gentle shockwaves inside the artery to break up hard calcium deposits that make blockages difficult to treat. In simple terms, it’s similar to how doctors break up kidney stones, but this is done inside the heart’s blood vessels to help them open more easily. By softening the hardened plaque, doctors can then safely place a stent to improve blood flow to the heart. This study is carefully evaluating how safe and effective this shockwave-based treatment is for patients with coronary artery disease. This study’s principal investigator is Nirat Beohar, MD, Director, Cardiac Catheterization Laboratory, Director, Interventional Cardiology Fellowship Program, Medical Director, Structural Heart Disease Program.