Two Pacing Methods After AV Node Ablation in Heart Failure With Atrial Fibrillation
Compares two heart pacing methods in adults with heart failure and atrial fibrillation.
Plain-language title generated from the registry record
Registry title: AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation
Key facts
- Where
- Florence, Lavagna, Milan, Nola, Reggio Emilia, Roma, and Tricase, ItalySee the 8 sites
Where in Italy
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNo longer taking part
- Department of Cardiology, Ospedali del TigullioLavagna, ItalyNo longer taking part
- Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San LucaMilan, ItalyNo longer taking part
- Ospedale San RaffaeleMilan, ItalyNo longer taking part
- Ospedale Santa Maria della PietaNola, ItalyNo longer taking part
- Department of Cardiology, Ospedale S. Maria NuovaReggio Emilia, ItalyNo longer taking part
- Ospedale San Pietro FatebenefratelliRoma, ItalyNo longer taking part
- Department of Cardiology, Ospedale PanicoTricase, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT07604727
- Record updated
- 22 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Patient who require any cardiac surgical intervention; NYHA functional class IV; Women who are pregnant or breastfeeding.