Status:
RECRUITING
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Atrial Fibrillation, Persistent
Heart Failure
Eligibility:
All Genders
60+ years
Phase:
NA
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...
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) i...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06207383
Start Date
October 1 2024
End Date
December 1 2028
Last Update
December 6 2024
Active Locations (18)
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1
St Elisabeth sister's Hospital
Graz, Austria
2
Antwerp University Hospital
Antwerp, Belgium
3
Acibadem City Clinic Tokuda University Hospital
Sofia, Bulgaria
4
University Hospital, Kralovske Vinohrady
Prague, Czechia