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NCT Number: NCT07405359

PVI Alone Versus PVI Plus PWI and SVCI With PFA

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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AF Ablation: PVI + PWI + SVCI

Procedure

Patients randomized to the 'PVI only' arm will be receiving an Afib ablation using PFA targeting the pulmonary veins for isolation (PVI). Following PVI, in those patients randomized to PVI+, PFA will also be used to isolate the left atrial posterior wall, and the superior vena cava.

PFA

Device

PFA is FDA-approved for PVI and PWI. SVCI using PFA will be done for investigational purposes.

implantable loop recorder

Procedure

Implantation of implantable loop recorder during ablation procedure for continuous heart monitoring during follow up.

Primary outcomes

  1. AF freedom

    Time frame: 12 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marialena Varympopioti, MS

CONTACT

[email protected]

415-514-7310

Sponsors and collaborators

Lead sponsor

Edward Gerstenfeld, MD

Other

Registry information

Official study title

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

Acronym: PVI-PLUS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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