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
NCT ID: NCT06878924
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
162 participants
OBSERVATIONAL
2025-05-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Willing to provide informed consent
* Age: 18-85 years
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Texas Cardiac Arrhythmia Research Foundation
OTHER
Responsible Party
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Andrea Natale
Executive Medical Director
Central Contacts
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Mitra Mohanty, MD MS
Role: CONTACT
Other Identifiers
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TCAI_SAVIOR
Identifier Type: -
Identifier Source: org_study_id
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