NCT06207383

Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure

Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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 (CSP+AVNA), 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. CSP+AVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization. 2. CSP+AVNA 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

Conditions

• Atrial Fibrillation, Persistent
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Conduction system pacing	Conduction system pacing (either His bundle pacing or left bundle branch area pacing)
PROCEDURE	Atrioventricular nodal ablation	Catheter ablation of the atrioventricular node
PROCEDURE	Atrial fibrillation ablation	Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)

Timeline

• Start date: 2024-10-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2024-01-17
• Last updated: 2024-12-06

Locations

18 sites across 14 countries: Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom