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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Conduction system pacing (either His bundle pacing or left bundle branch area pacing)
Catheter ablation of the atrioventricular node
Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)
St Elisabeth sister's Hospital
Graz, Austria
NOT_YET_RECRUITINGAntwerp University Hospital
Antwerp, Belgium
NOT_YET_RECRUITINGAcibadem City Clinic Tokuda University Hospital
Sofia, Bulgaria
NOT_YET_RECRUITINGUniversity Hospital, Kralovske Vinohrady
Prague, Czechia
NOT_YET_RECRUITINGHeart and Lung Center, University of Helsinki
Helsinki, Finland
RECRUITINGHôpital Charles Nicolle
Rouen, France
NOT_YET_RECRUITINGHerzzentrum Leipzig
Leipzig, Germany
NOT_YET_RECRUITINGSemmelweis University
Budapest, Hungary
NOT_YET_RECRUITINGBologna University Hospital
Bologna, Italy
NOT_YET_RECRUITINGUniversity Hospital Maastricht
Maastricht, Netherlands
NOT_YET_RECRUITING...and 8 more locations
Superiority endpoint
Incidence of mortality and cardiovascular hospitalization in each arm
Time frame: 1-4 years
Non-inferiority endpoint
Incidence of mortality and heart failure hospitalization in each arm
Time frame: 1-4 years
Minnesota Living with Heart Failure quality of life measure
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).
Time frame: 1 year
Left ventricular ejection fraction
Measurement using echocardiography
Time frame: 1 year
Complications
Peri-procedural and long-term
Time frame: 1-4 years
NYHA class
New York Heart Association classification of heart failure symptoms
Time frame: 1-4 years
Cost-Effectiveness Analysis
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.
Time frame: 1-4 years
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