PVI Alone Versus PVI Plus PWI and SVCI With PFA

NCT07405359 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 25-44799
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• AF freedom

  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

  12 months

Study Arms (2)

PVI alone

ACTIVE COMPARATOR

Afib ablation: PVI only

Device: PFA; Procedure: Implantable loop recorder

PVI + PWI + SVCI

EXPERIMENTAL

Afib ablation: PVI + PWI + SVCI

Procedure: AF Ablation: PVI + PWI + SVCI; Device: PFA; Procedure: Implantable loop recorder

Interventions

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.

PVI + PWI + SVCI

PFA DEVICE

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

PVI + PWI + SVCI; PVI alone

Implantable loop recorder PROCEDURE

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

PVI + PWI + SVCI; PVI alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Edward Gerstenfeld, MD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Gerstenfeld, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marialena Varympopioti, MS

CONTACT

415-514-7310; mariaeleni.varympopioti@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Medicine

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 12, 2026
• Study Start: February 14, 2026
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): August 14, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)