NCT07405359 PVI Alone Versus PVI Plus PWI and SVCI With PFA
| NCT ID | NCT07405359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edward Gerstenfeld, MD |
| Condition | Persistent Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2026-04-03 |
| Primary Completion | 2028-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2026-04-03 with a primary completion date of 2028-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Edward Gerstenfeld, MD, MS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07405359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07405359 currently recruiting?
Yes, NCT07405359 is actively recruiting participants. Contact the research team at mariaeleni.varympopioti@ucsf.edu for enrollment information.
Where is the NCT07405359 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07405359 clinical trial?
NCT07405359 is sponsored by Edward Gerstenfeld, MD. The principal investigator is Edward Gerstenfeld, MD, MS at University of California, San Francisco. The trial plans to enroll 220 participants.
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