PVI Alone Versus PVI Plus PWI and SVCI With PFA

Part of paid clinical trials in San Francisco, California.

Sponsor
Edward Gerstenfeld, MD
Study ID
NCT07405359
Status
Not Yet Recruiting

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Conditions

  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 Dates

Start date
Feb 14, 2026
Status verified
Feb 2026
Primary completion
Aug 14, 2028
Completion
Aug 14, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: PVI alone
    Afib ablation: PVI only
  • Experimental: PVI + PWI + SVCI
    Afib ablation: PVI + PWI + SVCI

Primary Outcome Measure

AF freedom [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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By research site
University of California, San Francisco· San Francisco, CA

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