Recruiting

PVI with VARIPULSE™

Sponsor:

Massachusetts General Hospital

Code:

NCT06099730

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pulsed Field Ablation (PFA)

Study Details

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

Study ID

NCT06099730

Start date

Dec 14, 2023

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

442 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Pulsed Field Ablation

This is a non-randomized one arm study.

Interventions

Pulsed Field Ablation (PFA)

PFA using Irreversible Electroporation (IRE) Ablation System

Primary outcome measure

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

Central Contacts and Locations

Locations

St. Bernard's Heart and Vascular Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Kayla Rubino

870-935-6729krubino@dnairresearch.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Grace Ha

617-643-1697gha2@mgh.harvard.edu

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

Contacts

Jose Matias

718-920-6442jmatias@montefiore.org

Texas Cardiac Arrhythmia Institute/Research Foundation

Recruiting

Austin, Texas, United States, 78705

Contacts

Chantel Scallon

512-522-9410cmscallon@austinheartbeat.com

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-27.