PVI Alone Versus PVI Plus PWI and SVCI With PFA

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

Catheter based ablation of atrial fibrillation (AF) is an established treatment modality for rhythm control of AF, with pulmonary vein isolation (PVI) being the cornerstone of this technique. While pulmonary vein triggers are the predominant arrhythmia mechanism in paroxysmal AF, development of additional atrial substrate contributes to maintenance of AF in persistent AF. This is likely to account for the lower rates of freedom from recurrent AF following ablation in patients with persistent AF. Various adjunctive empiric ablation strategies, such as left atrial posterior wall isolation (PWI), superior vena cava isolation (SVCI), linear ablation, and ablation of complex fractionated atrial electrograms have been studied to address this limitation of PVI alone. While observational data supports the safety and feasibility of Posterior Wall Isolation (PWI) and Superior Vena Cava Isolation (SVCI) with PFA, the efficacy of these strategies with PFA has not been demonstrated in randomized controlled trials. Whether mapping prior to ablation (i.e. detecting scar) predicts if PW and SVC sites are effective in improving ablation outcome is unknown. This study will test the hypothesis of whether empiric addition of PW and SVC isolation with PFA to PVI improves outcome (freedom from atrial tachyarrhythmia at 1-year). The investigators therefore propose a randomized controlled trial to compare the efficacy of Pulmonary Vein Isolation (PVI) alone versus PVI + PWI + SVCI in patients with persistent AF. The investigators hypothesize that the addition of PWI and SVCI to PVI in patients with persistent AF will provide improved freedom from AFIB off anti-arrhythmic drugs, without significantly increasing rates of procedural complications. Secondary analysis includes subgroups with posterior wall scar, procedure times, freedom from AFIB on or off anti arrhythmic drugs, etc.

Key facts

Study ID: NCT07405359
Run by: Edward Gerstenfeld, MD
People needed: 220
Starts: 2026-04-03
Expected to finish: 2028-08-14
Last updated by the study team: 2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

University of California, San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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