Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
- Conditions
- Atrial Fibrillation, PersistentHeart Failure
- Interventions
- Device: Conduction system pacingProcedure: Atrial fibrillation ablationProcedure: Atrioventricular nodal ablation
- Registration Number
- NCT06207383
- Lead Sponsor
- University Hospital, Geneva
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
(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
(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conduction system pacing + atrioventricular nodal ablation Atrioventricular nodal ablation Conduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node. Conduction system pacing + atrioventricular nodal ablation Conduction system pacing Conduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node. Atrial fibrillation ablation Atrial fibrillation ablation Catheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint.
- Primary Outcome Measures
Name Time Method Non-inferiority endpoint 1-4 years Incidence of mortality and heart failure hospitalization in each arm
Superiority endpoint 1-4 years Incidence of mortality and cardiovascular hospitalization in each arm
- Secondary Outcome Measures
Name Time Method NYHA class 1-4 years New York Heart Association classification of heart failure symptoms
Cost-Effectiveness Analysis 1-4 years Evaluation of clinical outcomes and associated costs between between the study arms. This evaluation will be conducted from a societal perspective, capturing both the direct medical costs and the broader societal impacts of the interventions.
Left ventricular ejection fraction 1 year Measurement using echocardiography
Minnesota Living with Heart Failure quality of life measure 1 year The questionnaire is comprised of 21 questions around physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0-5 scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is scored by summation of all 21 responses (the higher the score, the worse the quality of life).
Complications 1-4 years Peri-procedural and long-term
Trial Locations
- Locations (18)
Hôpital Charles Nicolle
🇫🇷Rouen, France
Bologna University Hospital
🇮🇹Bologna, Italy
St Elisabeth sister's Hospital
🇦🇹Graz, Austria
Antwerp University Hospital
🇧🇪Antwerp, Belgium
Acibadem City Clinic Tokuda University Hospital
🇧🇬Sofia, Bulgaria
University Hospital, Kralovske Vinohrady
🇨🇿Praha, Czech Republic
Heart and Lung Center, University of Helsinki
🇫🇮Helsinki, Finland
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
Semmelweis University
ðŸ‡ðŸ‡ºBudapest, Hungary
University Hospital Maastricht
🇳🇱Maastricht, Netherlands
Jagiellonian University
🇵🇱Kraków, Poland
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Madrid, Spain
University Hospital Geneva
🇨ðŸ‡Geneva, GE, Switzerland
University Hospital of Basel
🇨ðŸ‡Basel, Switzerland
Inselspital
🇨ðŸ‡Bern, Switzerland
University Hospital of Zurich
🇨ðŸ‡Zurich, Switzerland
National Heart and Lung Institute, Imperial College London
🇬🇧London, United Kingdom