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Studies

Interventional Recruiting

NCT06207383 on ClinicalTrials.gov

Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure

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

  • Sponsor: Geneva General Hospital
  • Collaborators: Swiss National Science Foundation
  • Enrollment: 220 (Estimated)
  • Study start: 2024-10-01 (Actual)
  • Primary completion: 2028-06-01 (Estimated)
  • Study completion: 2028-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Atrial Fibrillation, Persistent
  • Heart Failure

Intervention / Treatment

  • Device: Conduction system pacing
  • Procedure: Atrioventricular nodal ablation
  • Procedure: Atrial fibrillation ablation

Primary Outcome Measures

  • Superiority endpoint (1-4 years)
    Incidence of mortality and cardiovascular hospitalization in each arm
  • Non-inferiority endpoint (1-4 years)
    Incidence of mortality and heart failure hospitalization in each arm

Countries

Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Locations and Investigators

  • St Elisabeth sister's Hospital, Graz, Austria (Not yet recruiting)
    • Helmut Puerfellner
  • Antwerp University Hospital, Antwerp, Belgium (Not yet recruiting)
    • Hein Heidbuchel
  • Acibadem City Clinic Tokuda University Hospital, Sofia, Bulgaria (Not yet recruiting)
    • Vassil Traykov
  • University Hospital, Kralovske Vinohrady, Praha, Czech Republic (Not yet recruiting)
    • Karol Curila
  • Heart and Lung Center, University of Helsinki, Helsinki, Finland (Recruiting)
    • Jaarko Karvonen
  • Hôpital Charles Nicolle, Rouen, France (Not yet recruiting)
    • Fréderic Anselme
  • Herzzentrum Leipzig, Leipzig, Germany (Not yet recruiting)
    • Kerstin Bode
  • Semmelweis University, Budapest, Hungary (Not yet recruiting)
    • Laszlo Geller
  • Bologna University Hospital, Bologna, Italy (Not yet recruiting)
    • Mauro Biffi
  • University Hospital Maastricht, Maastricht, Netherlands (Not yet recruiting)
  • Jagiellonian University, Kraków, Poland (Not yet recruiting)
    • Marek Jastrzebski
  • Hospital Universitario La Paz, Madrid, Spain (Not yet recruiting)
    • Jose Merino
  • Hospital Universitario y Politecnico La Fe, Madrid, Spain (Not yet recruiting)
    • Oscar Cano
  • University Hospital Geneva, Geneva, Switzerland (Recruiting)
  • University Hospital of Basel, Basel, Switzerland (Recruiting)
    • Philipp Krisai
  • Inselspital, Bern, Switzerland (Recruiting)
  • University Hospital of Zurich, Zurich, Switzerland (Recruiting)
    • Alexander Breitenstein
  • National Heart and Lung Institute, Imperial College London, London, United Kingdom (Not yet recruiting)
    • Zachary Whinnett