Clinical trial NCT06207383: Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
Official title: Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Heart Failure
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2024-01-17
Enrollment: 220
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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

Eligibility criteria: Inclusion Criteria:

(i) Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure.

(ii) At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP \> 1000 pg/ml or BNP \> 250 pg/ml measured at any timepoint during this interval.

(iii) Previous or current rate or rhythm control drug therapy. (iv) Age \> 60 years

Exclusion Criteria:

(i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.

(ii) Life expectancy \< 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.

(vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.

Primary outcomes:
measure: Superiority endpoint
timeFrame: 1-4 years
measure: Non-inferiority endpoint
timeFrame: 1-4 years
Secondary outcomes:
measure: Minnesota Living with Heart Failure quality of life measure
timeFrame: 1 year
measure: Left ventricular ejection fraction
timeFrame: 1 year
measure: Complications
timeFrame: 1-4 years
measure: NYHA class
timeFrame: 1-4 years
measure: Cost-Effectiveness Analysis
timeFrame: 1-4 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: St Elisabeth sister's Hospital
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital
city: Praha
country: Czech Republic
facility: University Hospital, Kralovske Vinohrady
city: Helsinki
country: Finland
facility: Heart and Lung Center, University of Helsinki
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Budapest
country: Hungary
facility: Semmelweis University
city: Bologna
country: Italy
facility: Bologna University Hospital
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Kraków
country: Poland
facility: Jagiellonian University
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Geneva
country: Switzerland
facility: University Hospital Geneva
state: GE
city: Basel
country: Switzerland
facility: University Hospital of Basel
city: Bern
country: Switzerland
facility: Inselspital
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
city: London
country: United Kingdom
facility: National Heart and Lung Institute, Imperial College London
Study officials:
References: