PVI Alone vs PVI Plus PWI and SVCI with PFA in Persistent AF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two ablation strategies for persistent atrial fibrillation. All participants receive pulmonary vein isolation using pulsed-field ablation; the experimental approach adds posterior wall isolation and superior vena cava isolation. The study includes adults with persistent AF and plans to monitor outcomes after ablation using an implantable loop recorder. Key eligibility includes prior ablation exclusion, adequate LA size, and consent for post-procedure monitoring. Outcomes focus on rhythm control and safety, with enrollment at a single academic center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Edward Gerstenfeld, MD, MS — University of California, San Francisco
• Study coordinator: Marialena Varympopioti, MS
• Email: mariaeleni.varympopioti@ucsf.edu
• Phone: 415-514-7310

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation

  This trial tests the FARAFLEX Mapping and PFA System to see if it can safely help adults with drug-refractory paroxysmal or persistent atrial fibrillation.

  Recruiting at 13 sites Boston Scientific Corporation · Jonesboro, Arkansas and 12 other locations · NCT07575269

• Pulsed field ablation for atrial fibrillation in underrepresented minority patients

  This registry will test how well Boston Scientific pulsed field ablation works and how safe it is for Black, Hispanic, Asian, and other underrepresented adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 2 sites Icahn School of Medicine at Mount Sinai · New York, New York and 1 other locations · NCT07535268

• Left Atrial Appendage Occlusion and Rhythm Restoration in AF Patients

  This trial tests a combined procedure using the Volt PFA System and Amulet 2 to see if it safely and feasibly treats atrial fibrillation while also closing the left atrial appendage in adults with AF.

  Recruiting at 13 sites Abbott Medical Devices · Brussels, B CAP R and 15 other locations · NCT07523620

• Qidong Yixin Granules to prevent atrial fibrillation returning after ablation

  This trial tests whether taking Qidong Yixin Granules after catheter ablation can lower the chance of atrial fibrillation coming back within a year in adults with persistent AF.

  Recruiting Phase 4 Sir Run Run Shaw Hospital · Hangzhou and 4 other locations · NCT07508618

• FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation

  This will test new pulsed electrical waveforms delivered by the FARAPULSE PFA system to treat adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 3 sites Boston Scientific Corporation · Split and 3 other locations · NCT07444320

• Progressive Resistance Training First to Help AF and HFpEF Patients Feel Better

  This trial tests whether starting with progressive resistance training before aerobic exercise can improve exercise capacity and quality of life in people aged 60 and older who have atrial fibrillation and HFpEF.

  Recruiting Northwestern University · Chicago, Illinois · NCT07324772

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.