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Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF

NCT04506814 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-11-09

No results posted yet for this study

Summary

There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.

Conditions

  • Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation

Interventions

DEVICE

Endocardial PVI

Catheter based PVI

DEVICE

Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI

Minimally invasive PVI with posterior wall RF ablation + LAA clip + endocardial PVI

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    collaborator NETWORK

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506814 on ClinicalTrials.gov