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

NCT06099730 | Active Not Recruiting FDA Device

• 1 other identifier: 2023P002605
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 7

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Pulsed Field Ablation

OTHER

This is a non-randomized one arm study.

Device: Pulsed Field Ablation (PFA)

Interventions

Pulsed Field Ablation (PFA) DEVICE

PFA using Irreversible Electroporation (IRE) Ablation System

Pulsed Field Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (7)

St. Bernard's Heart and Vascular Center

Jonesboro, Arkansas, 72401, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Texas Cardiac Arrhythmia Institute/Research Foundation

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

US (7)