IRB Study Number 24-1158
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
You may be interested in taking part in this study if you have been diagnosed with symptomatic Paroxysmal Atrial Fibrillation (PAF), a type of atrial fibrillation where irregular and rapid heartbeat occur occasionally on and off, returning to a normal rhythm in less than 7 days without medical intervention. This condition may be contributing to your palpitations, chronic fatigue, weakness, shortness of breath, or pain. If you choose to be in this study, you will be scheduled for a cardiac ablation procedure utilizing the OMNYPULSE™ PFA Platform. Those who have had at least two symptomatic AF episodes within 6 months prior to enrollment, and at least 1 documented AF episode within 12 months prior to enrollment, failed at least one antiarrhythmic drug treatment or are unable to take them due to side effects or other clinical reasons, are 18 years of age or older and are willing to comply with anticoagulation (medication to thin blood) and arrhythmia (irregular heartbeat) monitoring requirements, will be eligible to participate in this study. Your participation in the research will last about 12 months following your ablation procedure.
Inclusion Criteria
- Symptomatic PAF with: a. At least two (2) symptomatic AF episodes within last six (6) months from enrollment, b. At least one (1) AF episode electrocardiographically documented within 12 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip, and c. A physician’s note indicating that the recurrent AF is self-terminating within 7 days
- Failed at least one (1) AAD (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable side effects to the AAD, or contraindication to the AAD
- Age 18-80 years
Exclusion Criteria
- Previously diagnosed with persistent AF (> 7 days in duration)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., untreated documented obstructive sleep apnea and acute alcohol toxicity)
- Previous surgical or catheter ablation for AF
- Documented LA thrombus by imaging within 48 hours of the procedure
- Documented severely compromised LVEF (LVEF <40%) by imaging within 6 months prior to enrollment
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- Documented thromboembolic event (including TIA) within the past 6 months
- Documented thromboembolic event (including TIA) within the past 6 months
- Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
