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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 1 year

Secondary outcomes

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

Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Natale, MD

CONTACT

[email protected]

5125448186

Mitra Mohanty, MD MS

CONTACT

512-544-8198

Sponsors and collaborators

Lead sponsor

Texas Cardiac Arrhythmia Research Foundation

Other

Registry information

Acronym: SAVIOR

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 17, 2025
Registry last updated: Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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