AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic … (NCT07604727) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation
France, Germany, Italy292 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The hierarchical composite endpoint of all-cause mortality, HF hospitalization or unplanned/urgent HF visit, and ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Timeframe: From enrollment to the end of follow up (median follow-up of 2.5 years)