Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: Pulsed Field Ablation (PFA)

• Registration Number: NCT06099730
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Study Start: 2023-12-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

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 within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
• Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
• Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
• Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
• Life expectancy less than 12 months
• Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulsed Field Ablation	Pulsed Field Ablation (PFA)	This is a non-randomized one arm study.

Primary Outcome Measures

Name	Time	Method
Incidence of early onset primary adverse events (PAEs)	within seven (7) days of an ablation procedure
Freedom from documented atrial tachyarrhythmia episodes	effectiveness evaluation period (Day 91-Day 365)
Freedom from acute procedural failure	during ablation procedure

Trial Locations

Locations (7)

St. Bernard's Heart and Vascular Center; 🇺🇸 Jonesboro, Arkansas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Montefiore Medical Center; 🇺🇸 New York, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Texas Cardiac Arrhythmia Institute/Research Foundation; 🇺🇸 Austin, Texas, United States