NCT07604727Not yet recruiting
AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 292 (estimated)
- First submitted
- 12 May 2026
- Start date
- Jul 2026
- Primary completion date
- Jun 2030
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07604727
What you commit to
- Study type: Interventional
- Planned participants: 292
- From Jul 2026 to the primary completion date, Jun 2030
- 23 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concomitant non-cardiac disease.
- 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.
Other illness
- Patient who require any cardiac surgical intervention.
Other
- NYHA functional class IV.
- Women who are pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marienhospital Gelsenkirchen Coordinator of this site? Confirm its status | Gelsenkirchen | Germany | Unknown status |
| University Medical Center Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Klinikum rechts der Isar Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| St. Vincenz-Krankenhaus GmbH Coordinator of this site? Confirm its status | Paderborn | Germany | Unknown status |
| Klinik für Kardiologie und Intensivmedizin Coordinator of this site? Confirm its status | Stade | Germany | Unknown status |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CHU La Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Clinique Pasteur - Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Department of Cardiology, Ospedali del Tigullio Coordinator of this site? Confirm its status | Lavagna | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale Santa Maria della Pieta Coordinator of this site? Confirm its status | Nola | Italy | Unknown status |
| Department of Cardiology, Ospedale S. Maria Nuova Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Ospedale San Pietro Fatebenefratelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Department of Cardiology, Ospedale Panico Coordinator of this site? Confirm its status | Tricase | Italy | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| FrisiusMC Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.