PVI Alone Versus PVI Plus PWI and SVCI With PFA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdward Gerstenfeld, MD

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AF Ablation: PVI + PWI + SVCI

    Procedure/Surgery

    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/Surgery

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: PVI aloneActive comparator 2 interventions
Group B: PVI + PWI + SVCIExperimental treatment 3 interventions

Trial outcomes

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edward Gerstenfeld, MD

Lead sponsor

University of California, San Francisco

Sponsor institution