Ablation Techniques for Atrial Fibrillation

(PVI-PLUS Trial)

Overseen By Marialena Varympopioti, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edward Gerstenfeld, MD

Disqualifiers: Stroke, Pacemaker, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Edward Gerstenfeld, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with persistent atrial fibrillation, which means they've had at least one AF episode lasting seven days or more. They must be able to follow the study's procedures and agree to have an implantable loop recorder for monitoring after ablation.

Inclusion Criteria

I am 18 years old or older.

I have signed the consent form and can follow the study's requirements.

I have had atrial fibrillation episodes lasting more than 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter-based ablation for atrial fibrillation, with either PVI alone or PVI + PWI + SVCI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for freedom from atrial tachyarrhythmia and procedural complications

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• AF Ablation: PVI + PWI + SVCI
• PFA

Trial Overview

The study compares two catheter-based ablation techniques for treating persistent AF: PVI alone versus a combination of PVI, PWI (Posterior Wall Isolation), and SVCI (Superior Vena Cava Isolation) using PFA technology. It aims to see if adding PWI and SVCI improves patients' freedom from arrhythmia without increasing complications.

How Is the Trial Designed?

Group I: PVI + PWI + SVCI Experimental Treatment 3 Interventions

Afib ablation: PVI + PWI + SVCI

Group II: PVI alone Active Control 2 Interventions

Afib ablation: PVI only

Who Is Running the Clinical Trial?

Edward Gerstenfeld, MD

Lead Sponsor