NCT06099730
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Recruiting
NAAges 18–80InterventionalTreatmentMassachusetts General HospitalInvestigator-initiated
~442 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Pulsed Field Ablation (PFA)
At a glance
Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of early onset primary adverse events (PAEs)
Measured over within seven (7) days of an ablation procedure
+2 more outcomes measured
Conditions
Where it's being run
6 sites across 4 statesMassachusetts2
New York2
Arkansas1
Texas1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Incidence of early onset primary adverse events (PAEs)within seven (7) days of an ablation procedure
- Freedom from documented atrial tachyarrhythmia episodeseffectiveness evaluation period (Day 91-Day 365)
- Freedom from acute procedural failureduring ablation procedure