Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
Recruiting · NCT06207383 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Geneva
View the official record on ClinicalTrials.gov →Interventions studied
Atrial fibrillation ablationAtrioventricular nodal ablationConduction system pacing
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
36 locations listed.
- Antwerp University Hospital - Antwerp, Belgium
- Antwerp University Hospital - Antwerp, Belgium
- University Hospital of Basel - Basel, Switzerland
- University Hospital of Basel - Basel, Switzerland
- Inselspital - Bern, Switzerland
- Inselspital - Bern, Switzerland
- Bologna University Hospital - Bologna, Italy
- Bologna University Hospital - Bologna, Italy
- Semmelweis University - Budapest, Hungary
- Semmelweis University - Budapest, Hungary
- St Elisabeth sister's Hospital - Graz, Austria
- St Elisabeth sister's Hospital - Graz, Austria
- Heart and Lung Center, University of Helsinki - Helsinki, Finland
- Heart and Lung Center, University of Helsinki - Helsinki, Finland
- Jagiellonian University - Krakow, Poland
- Jagiellonian University - Krakow, Poland
- Herzzentrum Leipzig - Leipzig, Germany
- Herzzentrum Leipzig - Leipzig, Germany
- National Heart and Lung Institute, Imperial College London - London, United Kingdom
- National Heart and Lung Institute, Imperial College London - London, United Kingdom
- University Hospital Maastricht - Maastricht, Netherlands
- University Hospital Maastricht - Maastricht, Netherlands
- Hospital Universitario La Paz - Madrid, Spain
- Hospital Universitario y Politecnico La Fe - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Hospital Universitario y Politecnico La Fe - Madrid, Spain
- University Hospital, Kralovske Vinohrady - Prague, Czechia
- University Hospital, Kralovske Vinohrady - Prague, Czechia
- Hôpital Charles Nicolle - Rouen, France
- Hôpital Charles Nicolle - Rouen, France
- Acibadem City Clinic Tokuda University Hospital - Sofia, Bulgaria
- Acibadem City Clinic Tokuda University Hospital - Sofia, Bulgaria
- University Hospital of Zurich - Zurich, Switzerland
- University Hospital of Zurich - Zurich, Switzerland
- University Hospital Geneva - Geneva, Canton of Geneva, Switzerland
- University Hospital Geneva - Geneva, Canton of Geneva, Switzerland