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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06878924
Acronym
SAVIOR
Enrollment
162
Registered
2025-03-17
Start date
2025-05-31
Completion date
2027-12-31
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

Persistent AF

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.

Interventions

None listed

Sponsors

Texas Cardiac Arrhythmia Research Foundation
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recurrence of atrial arrhythmia: any episode of AF/AT longer than 30 sec off-AAD, after the 2-month blanking period1 year

Secondary

MeasureTime frame
• Arrhythmia-free on previously ineffective AAD without any dose-escalation1 year

Contacts

Primary ContactAndrea Natale, MD
dr.natale@gmail.com5125448186
Backup ContactMitra Mohanty, MD MS
512-544-8198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026