NCT06099730Recruiting
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 442 (estimated)
- First submitted
- 19 Oct 2023
- Start date
- 14 Dec 2023
- Primary completion date
- Dec 2028
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06099730
What you commit to
- Study type: Interventional
- Planned participants: 442
- From 14 Dec 2023 to the primary completion date, Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgical or catheter ablation for AF
- Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
Other illness
- 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)
- Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
Age
- 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
Other
- Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Life expectancy less than 12 months
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Cardiac Arrhythmia Institute/Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| St. Bernard's Heart and Vascular Center Coordinator of this site? Confirm its status | Jonesboro | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.