Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Massachusetts General Hospital
Summary
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices * Age 18-80 years * Willing and capable of providing written consent * Able and willing to comply with all pre-, post- and follow-up testing and requirements. Exclusion Criteria: * Previous surgical or catheter ablation for AF * Documented LA thrombus by imaging wit…