IRB Study Number 24-320
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
We invite you to take part in a research study if you have a heart condition called atrial fibrillation (a condition where the heart beats rapidly and/or irregularly.) You may be considered to take part in this research study evaluating the Volt PFA System if your doctor has determined that this ablation system could be beneficial for treatment of your atrial fibrillation condition.
Pulsed field ablation (PFA) for atrial fibrillation (irregular heartbeat) is a procedure that involves using a catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) to deliver a pulsed electrical field in one or more areas of the upper left chamber of the heart that is causing the irregular heartbeat. The pulsed electric field creates a small scar on the heart tissue that is designed to block the electrical pathway that is causing the irregular heartbeat.
The purpose of this research study is to collect data to demonstrate safety and effectiveness for the treatment of atrial fibrillation using the Volt PFA system. The Volt PFA system is an investigational (experimental) device and is not approved by the Food and Drug Administration (FDA).
Inclusion Criteria
- Proven paroxysmal or persistent atrial fibrillation
- Plan to undergo a PVI catheter ablation procedure
- At least 18 years of age
- Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
Exclusion Criteria
- Previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
- Arrhythmia due to reversible causes
- Known presence of cardiac thrombus
- New York Heart Association (NYHA) class III or IV heart failure
- Body mass index > 40 kg/m2
- Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
- Certain cardiac conditions may exclude you from participating, including but not limited to: heart attack, stroke, hypertrophic cardiomyopathy, severe pulmonary disease, rheumatic heart disease
- Certain cardiac interventions may exclude you from participating, including but not limited to: prosthetic valves, stent, constriction, or stenosis in a pulmonary vein, implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator, implanted LAA closure device (i.e. Watchman)
- Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
