Clinical Research Directory
Browse clinical research sites, groups, and studies.
AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation
Sponsor: University Medical Center Groningen
Summary
The goal of this clinical trial is to learn if conduction system pacing works as well as cardiac resynchronization therapy (CRT) post atrioventricular (AV) node ablation in adult patients with symptomatic heart failure and atrial fibrillation that is not suitable for rhythm control. The main question it aims to answer is: Is AV node ablation with conduction system pacing noninferior to AV node ablation with CRT for the hierarchical composite outcome of all-cause mortality, heart failure hospitalization or urgent heart failure visit, and meaningful improvement in heart failure-related quality of life? Participants will undergo: * An AV node ablation and be randomly assigned to receive either a conduction system pacing or a CRT. * Attend follow-up visits (in clinic or by telephone) at baseline, intervention day, 3-month, 12-month, 24-month, and 36-month after the procedure. * Complete questionnaires about heart failure symptoms and quality of life at baseline, 12 months, and yearly. * Have an echocardiogram, an electrocardiogram, and blood tests at baseline and 1 year * At selected centers: they will be asked to wear a bracelet that measures arterial stiffness for 30 minutes and provide a urine sample at baseline and 1 year.
Official title: AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation: The APAF-CSP All-cause Mortality and Quality of Life Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
292
Start Date
2026-07
Completion Date
2030-06
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
Conduction System Pacing
The implantation of a pacing device with a pacing lead that aims to capture and pace the native conduction system.
Cardiac resynchronization therapy
The implantation of a pacing device with a pacing leads that aims to capture and pace both ventricles in a synchronized fashion, to achieve the best possible hemodynamic parameters and synchrony.
Locations (23)
CHU de Grenoble
Grenoble, France
CHU la Timone
Marseille, France
Hôpital Européen Georges Pompidou
Paris, France
CHU de Rouen
Rouen, France
Clinique Pasteur Toulouse
Toulouse, France
Marienhospital Gelsenkirchen
Gelsenkirchen, Germany
University Medical Center Mainz
Mainz, Germany
Klinikum rechts der Isar
München, Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, Germany
Klinik für Kardiologie und Intensivmedizin
Stade, Germany
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Department of Cardiology, Ospedali del Tigullio
Lavagna, Italy
Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Ospedale Santa Maria della Pieta
Nola, Italy
Department of Cardiology, Ospedale S. Maria Nuova
Reggio Emilia, Italy
Ospedale San Pietro Fatebenefratelli
Roma, Italy
Department of Cardiology, Ospedale Panico
Tricase, Italy
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
FrisiusMC
Leeuwarden, Netherlands
Maastricht UMC
Maastricht, Netherlands
Antonius Hospital
Nieuwegein, Netherlands