Atrial Fibrillation, Persistent, Heart Failure
Conditions
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
Interventions
DEVICEConduction system pacing
Conduction system pacing (either His bundle pacing or left bundle branch area pacing)
PROCEDUREAtrioventricular nodal ablation
Catheter ablation of the atrioventricular node
PROCEDUREAtrial fibrillation ablation
Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)
Sponsors
Swiss National Science Foundation
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superiority endpoint | 1-4 years | Incidence of mortality and cardiovascular hospitalization in each arm |
| Non-inferiority endpoint | 1-4 years | Incidence of mortality and heart failure hospitalization in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 1-4 years | Peri-procedural and long-term |
| 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). |
| 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. |
| NYHA class | 1-4 years | New York Heart Association classification of heart failure symptoms |
| Left ventricular ejection fraction | 1 year | Measurement using echocardiography |
Countries
Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Contacts
Primary ContactHaran Burri
Backup ContactNikola Kozhuharov
Outcome results
None listed