Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conduction system pacing, Atrioventricular nodal ablation, Atrial fibrillation ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Persistent, Heart Failure. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Bulgaria, Czechia, Finland +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
Overview
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
Interventions
- 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)
Primary outcome measures
- Superiority endpoint [Time frame: 1-4 years]
- Non-inferiority endpoint [Time frame: 1-4 years]
Secondary outcome measures (5)
- Minnesota Living with Heart Failure quality of life measure [Time frame: 1 year]
- Left ventricular ejection fraction [Time frame: 1 year]
- Complications [Time frame: 1-4 years]
- NYHA class [Time frame: 1-4 years]
- Cost-Effectiveness Analysis [Time frame: 1-4 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Switzerland · 4 centers
- University Hospital Geneva — Geneva
- University Hospital of Basel — Basel
- Inselspital — Bern
- University Hospital of Zurich — Zurich
Spain · 2 centers
- Hospital Universitario La Paz — Madrid
- Hospital Universitario y Politecnico La Fe — Madrid
Austria · 1 center
- St Elisabeth sister's Hospital — Graz
Belgium · 1 center
- Antwerp University Hospital — Antwerp
Bulgaria · 1 center
- Acibadem City Clinic Tokuda University Hospital — Sofia
Czechia · 1 center
- University Hospital, Kralovske Vinohrady — Prague
Finland · 1 center
- Heart and Lung Center, University of Helsinki — Helsinki
France · 1 center
- Hôpital Charles Nicolle — Rouen
Germany · 1 center
- Herzzentrum Leipzig — Leipzig
Hungary · 1 center
- Semmelweis University — Budapest
Italy · 1 center
- Bologna University Hospital — Bologna
Netherlands · 1 center
- University Hospital Maastricht — Maastricht
Poland · 1 center
- Jagiellonian University — Krakow
United Kingdom · 1 center
- National Heart and Lung Institute, Imperial College London — London
Identifiers
NCT: NCT06207383 · SNF_32003B_220116