Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF

Not Applicable

Withdrawn

• Conditions: Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation
• Interventions: Device: Endocardial PVI; Device: Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI

• Registration Number: NCT04506814
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

In these redo ablation patients, the ideal re-ablation strategy is unknown and many techniques have been proposed but there is no consensus nor strong clinical trial data.

This treatment gap prompted the development of a combined minimally invasive epicardial and endocardial ablation ("Convergent") procedure. During the last decade, this "hybrid" approach has garnered increasing acceptance in clinical practice, with several reports of promising antiarrhythmic outcomes in challenging disease states, as well as modifications to maximize safety and clinical outcomes. One key aspect of this approach is that it targets key drivers of AF including the PVs but also the left atrial posterior wall (LAPW), combining endocardial and epicardial energy delivery. The LAPW (or "PV myocardium") shares similar embryological origins and electrophysiological properties with the PVs, is predisposed to develop fibrosis, and thus recognized as an important source of AF. Recently, the CONVERGE randomized clinical trial demonstrated superiority of this hybrid approach compared to PVI in patients with persistent AF.

The left atrial appendage (LAA) has also been designated as a potential important trigger site of AF, and if isolated, may result in improved post-ablation AF outcomes. Although catheter-based isolation is controversial due to the potential to increase the risk of stroke, surgical exclusion of the LAA by placement of an occlusive clip has been suggested to be both antiarrhythmic and anti-thrombotic. Thus it is proposed in this trial to incorporate the LAA clip within the hybrid procedure.

Given the sheer volume of patients undergoing ablation of AF and the predictable necessity to perform repeat ablation procedures on a portion of these patients, the need for a proven redo ablation strategy is self-evident. The investigators thus propose a randomized clinical trial to determine if there is incremental efficacy by performing LAPW/LAA isolation via a hybrid approach in comparison to the conventional redo PVI alone in patients with paroxysmal AF.

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Study Start: 2025-01
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocardial PVI	Endocardial PVI	Endocardial complete PVI
Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI	Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI	Minimally invasive surgical hybrid ablation using the convergent approach plus LAA exclusion using the clip

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation > 30 secs	At 1 year	Based on serial 7-day Holter recordings

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Short Hills, New Jersey, United States