Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207383
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-17
Brief Title:
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation With Conduction System Pacing in Heart Failure
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation With CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABACUS
Brief Summary:
The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure who are eligible for atrial fibrillation ablation Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation The effect of treatment allocation on total mortality cardiovascular hospitalization and heart failure hospitalization will be compared
Detailed Description:
Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation CSPAVNA versus atrial fibrillation AF ablation by pulmonary vein isolation PVI in patients with persistent atrial fibrillation AF and heart failure HF to guide future management of these patients
Hypotheses
1 CSPAVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization
2 CSPAVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization
Design Investigator-initiated prospective randomized controlled open-label multicentre study conducted in 30 centres from 14 countries in Europe with expertise in CSP and AF ablation
Sample size 220 patients
Study duration 4 years
Hypotheses
1 CSPAVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization
2 CSPAVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization
Design Investigator-initiated prospective randomized controlled open-label multicentre study conducted in 30 centres from 14 countries in Europe with expertise in CSP and AF ablation
Sample size 220 patients
Study duration 4 years
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None