Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• (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

Locations
Other Locations
Austria
St Elisabeth sister's Hospital
NOT_YET_RECRUITING
Graz
Belgium
Antwerp University Hospital
NOT_YET_RECRUITING
Antwerp
Bulgaria
Acibadem City Clinic Tokuda University Hospital
NOT_YET_RECRUITING
Sofia
Finland
Heart and Lung Center, University of Helsinki
RECRUITING
Helsinki
France
Hôpital Charles Nicolle
NOT_YET_RECRUITING
Rouen
Germany
Herzzentrum Leipzig
NOT_YET_RECRUITING
Leipzig
Hungary
Semmelweis University
NOT_YET_RECRUITING
Budapest
Italy
Bologna University Hospital
NOT_YET_RECRUITING
Bologna
Netherlands
University Hospital Maastricht
NOT_YET_RECRUITING
Maastricht
Poland
Jagiellonian University
NOT_YET_RECRUITING
Krakow
Spain
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario y Politecnico La Fe
NOT_YET_RECRUITING
Madrid
Switzerland
University Hospital of Basel
RECRUITING
Basel
Inselspital
RECRUITING
Bern
University Hospital Geneva
RECRUITING
Geneva
University Hospital of Zurich
RECRUITING
Zurich
United Kingdom
National Heart and Lung Institute, Imperial College London
NOT_YET_RECRUITING
London
Contact Information
Primary
Haran Burri
haran.burri@hcuge.ch
+41794616217
Backup
Nikola Kozhuharov
nikola.kozhuharov@googlemail.com
+41764439086
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 220
Treatments
Other: Atrial fibrillation ablation
Catheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint.
Active_comparator: Conduction system pacing + atrioventricular nodal ablation
Conduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node.
Sponsors
Leads: University Hospital, Geneva
Collaborators: Swiss National Science Foundation

This content was sourced from clinicaltrials.gov