NCT07405359Recruiting
PVI Alone Versus PVI Plus PWI and SVCI With PFA
A Randomized Trial of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation Plus Posterior Wall and Superior Vena Cava Isolation With Pulsed Field Ablation for Treatment of Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 3 Apr 2026
- Primary completion date
- 14 Aug 2028
- Lead sponsor
- Edward Gerstenfeld, MD
- Diseases
- Atrial fibrillation
- NCT number
- NCT07405359
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 3 Apr 2026 to the primary completion date, 14 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Left atrial appendage occlusion or closure device \< 6 mos or with leak or prior DRT
Other illness
- Congenital heart disease with residual anatomic abnormality
- Refusal to receive ICM implant or allergy to ICM
Lab values
- Left ventricular ejection fraction \<30%
- Baseline creatinine \>2.0 mg/dL
Age
- Longstanding persistent AF (\> 3 years)
Other
- Implanted pacemaker or defibrillator
- LA volume \>80ml/m2
- Atrial septal occlusion device
- Current left atrial thrombus
- Mitral or Tricuspid valve clip or mechanical replacement or clip
- Hypertrophic cardiomyopathy
- Contraindication to femoral vascular access
- Contraindication to, or unwillingness to use, systemic anticoagulation
- Pregnancy
- Predicted life expectancy less than one year
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.