PVI Alone Versus PVI Plus PWI and SVCI With PFA for Persistent Atrial Fibrillation

This study is testing a procedure called AF ablation (a treatment for an irregular heartbeat called atrial fibrillation) for people with persistent atrial fibrillation. It compares two approaches: one where only the pulmonary veins are isolated (PVI), and another where the pulmonary veins, left atrial posterior wall, and superior vena cava are isolated (PVI + PWI + SVCI). Both approaches use a device called PFA. The study aims to see if adding PWI and SVCI improves freedom from atrial fibrillation after 12 months. You may be able to join if you are 18 or older, have persistent atrial fibrillation, and are interested in having an implantable loop recorder for monitoring. The study is currently unclear on its recruitment status and plans to enroll 220 participants.

Study design
This is an interventional study comparing two different ablation procedures for atrial fibrillation. It plans to enroll 220 participants.
What's involved
You would undergo an AF ablation procedure, which includes the implantation of an implantable loop recorder for continuous heart monitoring.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for freedom from atrial fibrillation for 12 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07405359

PVI Alone Versus PVI Plus PWI and SVCI With PFA

Recruiting
NAAges 18+InterventionalTreatment
Edward Gerstenfeld, MD
~220 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:AF Ablation: PVI + PWI + SVCIPFAImplantable loop recorder

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AF freedom
Measured over 12 months
Persistent Atrial Fibrillation

NCT07405359

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California, San Francisco

    San Francisco, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Edward Gerstenfeld, MD, MS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Eligibility criteria

Inclusion

Age ≥18 years at their pre-procedure visit
Persistent AF, defined as at least one continuous AF episode lasting at least seven days in duration, documented by a continuous monitor or 2 ECGs\>7 days apart or ≥3 cardioversions
Indicated and interested in ICM implant for monitoring post ablation
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

Exclusion

Any prior atrial endocardial or epicardial ablation procedure, other than cavotricuspid isthmus ablation or supraventricular tachycardia
Stroke or transient ischemic attack within the previous six months
Gastrointestinal bleeding within the previous three months
Implanted pacemaker or defibrillator
Longstanding persistent AF (\> 3 years)
LA volume \>80ml/m2
Atrial septal occlusion device
Current left atrial thrombus
Left atrial appendage occlusion or closure device \< 6 mos or with leak or prior DRT
Mitral or Tricuspid valve clip or mechanical replacement or clip
Hypertrophic cardiomyopathy
Contraindication to femoral vascular access
Congenital heart disease with residual anatomic abnormality
Contraindication to, or unwillingness to use, systemic anticoagulation
Pregnancy
Left ventricular ejection fraction \<30%
Baseline creatinine \>2.0 mg/dL
Predicted life expectancy less than one year
Refusal to receive ICM implant or allergy to ICM
  • AF freedom12 months

    First recurrence of AT/AFL/AF \> 1 hour after a 2-month blanking period Any 1) cardioversion 2) redo ablation or 3) escalation/change in AAD after the 2-month blanking period (allowing 3 months to stop AADs) is considered a failure of the primary endpoint