Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT06182566
Status:
WITHDRAWN
Last Update Posted:
2024-07-19
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
A Pilot Randomized Trial of Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure CONVERGE-HF
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Department feasibility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONVERGE-HF
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: