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NOT YET RECRUITING
NCT07604727
NA

AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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

PROCEDURE

Conduction System Pacing

The implantation of a pacing device with a pacing lead that aims to capture and pace the native conduction system.

PROCEDURE

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