NCT06099730 Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
| NCT ID | NCT06099730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 442 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 442 participants in total. It began in 2023-12-14 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06099730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06099730 currently recruiting?
Yes, NCT06099730 is actively recruiting participants. Visit ClinicalTrials.gov or contact Massachusetts General Hospital to inquire about joining.
Where is the NCT06099730 trial being conducted?
This trial is being conducted at Jonesboro, United States, Boston, United States, Boston, United States, New York, United States and 2 additional locations.
Who is sponsoring the NCT06099730 clinical trial?
NCT06099730 is sponsored by Massachusetts General Hospital. The trial plans to enroll 442 participants.
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