Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation, Persistent, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT06207383
- Run by
- University Hospital, Geneva
- People needed
- 220
- Starts
- 2024-10-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2024-12-06
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (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
You may not qualify if…
- (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.
Where it is running
- University Hospital Geneva — Geneva, Canton of Geneva, Switzerland (enrolling)
- University Hospital of Basel — Basel, Switzerland (enrolling)
- Inselspital — Bern, Switzerland (enrolling)
- University Hospital of Zurich — Zurich, Switzerland (enrolling)
- Heart and Lung Center, University of Helsinki — Helsinki, Finland (enrolling)
- Herzzentrum Leipzig — Leipzig, Germany
- Semmelweis University — Budapest, Hungary
- Bologna University Hospital — Bologna, Italy
- University Hospital Maastricht — Maastricht, Netherlands
- Jagiellonian University — Krakow, Poland
- Hospital Universitario La Paz — Madrid, Spain
- Hospital Universitario y Politecnico La Fe — Madrid, Spain
- St Elisabeth sister's Hospital — Graz, Austria
- National Heart and Lung Institute, Imperial College London — London, United Kingdom
- Antwerp University Hospital — Antwerp, Belgium
- Acibadem City Clinic Tokuda University Hospital — Sofia, Bulgaria
- University Hospital, Kralovske Vinohrady — Prague, Czechia
- Hôpital Charles Nicolle — Rouen, France
Full record on ClinicalTrials.gov
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