AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation
Starting soon · Not applicable
Conditions studied: Atrial Fibrillation (AF), Heart Failure, Cardiac Pacing
In brief
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.
Key facts
- Study ID
- NCT07604727
- Run by
- University Medical Center Groningen
- People needed
- 292
- Starts
- 2026-07-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or above.
- Patient is diagnosed with AF and deemed not amenable to rhythm control. This diagnosis of AF will be demonstrated by at least one Electrocardiograph (ECG) showing AF that was performed within one year prior to enrollment.
- Has history of stable heart failure (regardless left ventricular ejection fraction) and has a history of at least one HF related hospitalization or emergency room/urgent care visit within 2 years prior to enrollment, despite being on maximally tolerable guideline directed medical therapy.
- Willing and capable to provide informed consent.
You may not qualify if…
- NYHA functional class IV.
- Severe concomitant non-cardiac disease.
- Patient who require any cardiac surgical intervention.
- Previously implanted pacing devices (pacemaker/ICD/CRT) with ≥40% pacing burden.
- Any of the following within the 3 months prior to enrollment:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Stroke or TIA
- Significant bleeding
- Pericarditis/effusions
- Coronary artery bypass surgery/atriotomy within 6 months prior to enrolment.
- Women who are pregnant or breastfeeding.
Where it is running
- 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
Full record on ClinicalTrials.gov
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