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 (SAVIOR)

Texas Cardiac Arrhythmia Research Foundation

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Study type: Observational

Funder types: Other

Identifiers

NCT06878924

TCAI_SAVIOR

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• • 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

Trial design

162 participants in 2 patient groups

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

Description:

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

Description:

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.