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

Last updated: June 5, 2026
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Dysrhythmia

Chest Pain

Treatment

Pulsed Field Ablation (PFA)

Clinical Study ID

NCT06099730
2023P002605
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic paroxysmal and persistent AF with at least one AF episodeelectrocardiographically 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 consumerdevices

  • Age 18-80 years

  • Willing and capable of providing written consent

  • Able and willing to comply with all pre-, post- and follow-up testing andrequirements.

Exclusion

Exclusion Criteria:

  • Previous surgical or catheter ablation for AF

  • Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, orintracardiac 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 toanticoagulation (heparin, warfarin, or dabigatran)

  • Significant congenital anomaly or medical problem that in the opinion of theinvestigator would preclude enrollment in this study

  • Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) orother 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 thecourse 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

Total Participants: 442
Treatment Group(s): 1
Primary Treatment: Pulsed Field Ablation (PFA)
Phase:
Study Start date:
December 14, 2023
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • St. Bernard's Heart and Vascular Center

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Montefiore Medical Center

    New York, New York 10467
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Institute/Research Foundation

    Austin, Texas 78705
    United States

    Active - Recruiting

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