NCT06182566

Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure

A Pilot Randomized Trial of Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure CONVERGE-HF

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pilot, randomized, unblinded, feasibility and proof of concept clinical trial randomizing 50 patients in a 1:1 ratio to hybrid ablation or catheter ablation

Detailed description

To determine if a hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent AF. Hypothesis: Hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent AF in terms of mortality and worsening heart failure, AF rhythm control and improvement in LVEF, quality of life, and 6-minute walk distance.

Conditions

• Atrial Fibrillation
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Convergent ablation	Staged hybrid ablation with CONVERGENT epicardial ablation with ablation of the ligament of Marshall and left atrial appendage clip, followed in second stage by endocardial catheter ablation including pulmonary vein isolation and posterior wall ablation with roof and inferior posterior lines in addition to targeting and touching up any areas with signals at the posterior wall
PROCEDURE	Catheter ablation	Pulmonary vein isolation using commercially available catheters; including pulmonary vein isolation and posterior wall ablation with roof and inferior posterior lines in addition to targeting and touching up any areas with signals at the posterior wall

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-12-31
• Completion: 2027-07-01
• First posted: 2023-12-27
• Last updated: 2024-07-19