Clinical trials
Whether you are exploring participation or referring a patient, our research office can help you understand study availability and the next steps.
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Heart failure · catheter-based research
Our center’s research experience includes Corvia’s REDUCE LAP-HF program, V-Wave’s RELIEVE-HF, Occlutech’s FROST-HF, and work with Alleviant Medical through ALLAY-HF. These programs explore whether an opening between the heart’s upper chambers can help selected people with heart failure.
In some people with heart failure, pressure rises in the left atrium and can contribute to breathlessness. An interatrial shunt creates a small opening in the wall between the upper chambers, allowing blood to flow from the left atrium toward the right atrium. Researchers study whether this can lower pressure and improve symptoms or outcomes.
Corvia, V-Wave, and Occlutech programs use implanted shunt devices. Alleviant’s approach creates an opening without a permanent implant. These strategies differ in their design and the patients studied; evidence from one system does not establish the effectiveness of another.
Corvia Medical
Studied an implanted interatrial shunt in people with heart failure and preserved or mildly reduced ejection fraction. The overall randomized trial did not show clinical benefit compared with a sham procedure; subsequent research examines which patients might respond.
Read study information ↗V-Wave
Evaluated the V-Wave interatrial shunt against a placebo procedure in symptomatic heart failure. Results did not show overall benefit, and outcomes differed between reduced and preserved ejection-fraction groups, underscoring the importance of patient selection.
Read study information ↗Occlutech
A randomized, sham-controlled study evaluating the safety and effectiveness of the Atrial Flow Regulator in symptomatic heart failure. The implanted device creates a controlled opening between the atria.
Read study information ↗Alleviant Medical
Evaluates the Alleviant System for creating an interatrial opening without leaving a permanent implant. The randomized, sham-controlled program studies safety and effectiveness in heart failure with preserved ejection fraction.
Read study information ↗Shunting changes blood flow and may add workload to the right side of the heart. Benefits are not established for every patient, and some groups may experience harm. Procedures and implanted devices carry risks. A study team can explain the protocol, alternatives, and what is known before you decide whether to participate.
This is research background and our center’s study experience, not a statement of current enrollment. Contact the research office to confirm availability, eligibility, and the requirements of an individual study.
AFib research · published evidence
Pulsed field ablation (PFA) uses brief electrical pulses to treat heart tissue involved in abnormal rhythms, rather than relying on heat or freezing. In atrial fibrillation (AFib), ablation commonly aims to isolate electrical signals coming from the pulmonary veins.
1,568
Patients in the registry
24
European centers
78.1%
Estimated freedom from atrial arrhythmia at one year
The 2023 MANIFEST-PF report followed patients receiving PFA in routine care. Its one-year result measured freedom from documented AFib, atrial flutter, or atrial tachycardia lasting at least 30 seconds after a three-month post-procedure period. Patients could be taking rhythm medicines. Acute major adverse events occurred in 1.9% of patients.
This was an observational registry, not a randomized comparison with heat- or freezing-based ablation. It supports understanding of PFA in everyday practice, but does not prove it is better than another treatment or predict your individual outcome. Ablation carries risks, and AFib can return. Discuss treatment options with your electrophysiologist.
This section summarizes published research. It does not indicate ACRC participation in MANIFEST-PF or current enrollment. Contact our research office about study opportunities at our site.
Invasive & structural heart research
Our clinical research program has been among the world’s largest sites for left atrial appendage closure. Our investigators’ experience includes participation in PROTECT AF, PREVAIL, WATCHMAN FLX research, and Amulet IDE—studies exploring device-based approaches to stroke prevention in atrial fibrillation.
The left atrial appendage is a small pouch in the heart where clots can form in people with AFib. Catheter-based closure places a device at its opening to help reduce stroke risk in selected patients. It addresses stroke prevention; it does not treat the abnormal rhythm itself.
WATCHMAN
A randomized trial comparing left atrial appendage closure with WATCHMAN against warfarin for stroke prevention in people with nonvalvular atrial fibrillation.
Read published study information ↗WATCHMAN
A randomized study examining the safety and effectiveness of WATCHMAN compared with long-term warfarin therapy in nonvalvular atrial fibrillation.
Read published study information ↗WATCHMAN FLX
Experience with the next generation of WATCHMAN technology. The published PINNACLE FLX trial evaluated procedural safety and appendage closure with this device.
Read published study information ↗Amplatzer Amulet
A randomized trial comparing the Amulet occluder with the first-generation WATCHMAN device for stroke prevention in nonvalvular atrial fibrillation.
Read published study information ↗Closure is not suitable for everyone and does not eliminate all stroke risk. Implantation carries risks, including bleeding and procedural complications. Follow-up imaging and blood-thinning medicines may still be needed. Your clinician can explain the choices for your circumstances.
These studies describe our investigators’ research experience and published evidence. They are not current recruitment listings. Contact the research office to ask about studies available at ACRC.
