Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation, Persistent
- Sponsor
- University Hospital, Geneva
- Enrollment
- 220
- Locations
- 18
- Primary Endpoint
- Non-inferiority endpoint
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
Haran Burri, MD
Chief Investigator and Sponsor Representative
University Hospital, Geneva
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.
Outcomes
Primary Outcomes
Non-inferiority endpoint
Time Frame: 1-4 years
Incidence of mortality and heart failure hospitalization in each arm
Superiority endpoint
Time Frame: 1-4 years
Incidence of mortality and cardiovascular hospitalization in each arm
Secondary Outcomes
- NYHA class(1-4 years)
- Cost-Effectiveness Analysis(1-4 years)
- Left ventricular ejection fraction(1 year)
- Minnesota Living with Heart Failure quality of life measure(1 year)
- Complications(1-4 years)