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

ConditionAtrial Fibrillation (AF)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-85

SponsorTexas Cardiac Arrhythmia Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptomatic persistent AF; 1st or redo ablation with PVI-only in the earlier procedure

Willing to provide informed consent

Age: 18-85 years

Disqualifiers

• Previous PWI or VoM ablation procedure

Left ventricular ejection fraction <40%

Left atrial thrombus

Myocardial infarction within last 60 days

Trial population

Persistent atrial fibrillation

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

162 Participants

are grouped into 2 trial groups

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

Group B: PFA-based PVI+ left atrial posterior wall isolation

Trial outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas Cardiac Arrhythmia Research Foundation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: