Safety and Efficacy of Pulmonary Vein Isolation Using Pulsed-field Ablation (PFA) Combined with Either PFA-based Left Atrial Posterior Wall Isolation or Vein of Marshall Ethanol Ablation in Patients with Persistent Atrial Fibrillation

NCT06878924 | Not Yet Recruiting

• 1 other identifier: TCAI_SAVIOR
• Study Type: observational
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.

Conditions

Atrial Fibrillation (AF)

Keywords

Persistent AF

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial arrhythmia: any episode of AF/AT longer than 30 sec off-AAD, after the 2-month blanking period

  1 year

Secondary Outcomes (1)

• • Arrhythmia-free on previously ineffective AAD without any dose-escalation

  1 year

Study Arms (2)

Persistent AF patients receiving PVI (PFA)+ VoM alcohol ablation

PVI: General periprocedural guidance includes target activated clotting time (ACT) ≥350, catheter exchange ≤2, \>10s spacing of consecutive applications, and minimization of number of PF applications per the recommended procedures below: For each pulmonary vein, a concentric ring of applications will be created using 12 (6 ostial and 6 antral) applications In case of visual gaps, additional 8 applications will be added PWI: Concentric overlapping ablations will be placed throughout the posterior wall deliberately. The catheter will be rotated once between a pair of applications; briefly, rotation is performed such that, post-rotation, the splines are situated midway between the splines' pre- rotation positions. The number of applications will be at the operator's discretion. VoM: VoM alcohol ablation procedure will be conducted before the catheter ablation. VoM will be visualized by coronary sinus venography, cannulated with an angioplasty wire and balloon and 1 cc of 98% ethanol will

PFA-based PVI+ left atrial posterior wall isolation

PVI: General periprocedural guidance includes target activated clotting time (ACT) ≥350, catheter exchange ≤2, \>10s spacing of consecutive applications, and minimization of number of PF applications per the recommended procedures below: For each pulmonary vein, a concentric ring of applications will be created using 12 (6 ostial and 6 antral) applications In case of visual gaps, additional 8 applications will be added PWI: Concentric overlapping ablations will be placed throughout the posterior wall deliberately. The catheter will be rotated once between a pair of applications; briefly, rotation is performed such that, post-rotation, the splines are situated midway between the splines' pre- rotation positions. The number of applications will be at the operator's discretion.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Persistent atrial fibrillation

You may qualify if:

• Symptomatic persistent AF; 1st or redo ablation with PVI-only in the earlier procedure
• Willing to provide informed consent
• Age: 18-85 years

You may not qualify if:

• Previous PWI or VoM ablation procedure
• Left ventricular ejection fraction \<40%
• Left atrial thrombus
• Myocardial infarction within last 60 days
• Cardiac surgery in the last 6 months
• Advanced renal failure
• Life expectancy \<1 year
• Pregnant women
• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrea Natale, MD

CONTACT

5125448186; dr.natale@gmail.com

Mitra Mohanty, MD MS

CONTACT

512-544-8198

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share