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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
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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Marienhospital Gelsenkirchen
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GelsenkirchenGermanyUnknown status
University Medical Center Mainz
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MainzGermanyUnknown status
Klinikum rechts der Isar
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MünchenGermanyUnknown status
St. Vincenz-Krankenhaus GmbH
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PaderbornGermanyUnknown status
Klinik für Kardiologie und Intensivmedizin
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StadeGermanyUnknown status
CHU de Grenoble
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GrenobleFranceUnknown status
CHU La Timone
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MarseilleFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
CHU de Rouen
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RouenFranceUnknown status
Clinique Pasteur - Toulouse
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ToulouseFranceUnknown status
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyUnknown status
Department of Cardiology, Ospedali del Tigullio
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LavagnaItalyUnknown status
Ospedale San Raffaele
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MilanItalyUnknown status
Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca
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MilanItalyUnknown status
Ospedale Santa Maria della Pieta
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NolaItalyUnknown status
Department of Cardiology, Ospedale S. Maria Nuova
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Reggio EmiliaItalyUnknown status
Ospedale San Pietro Fatebenefratelli
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RomaItalyUnknown status
Department of Cardiology, Ospedale Panico
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TricaseItalyUnknown status
University Medical Center Groningen
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GroningenNetherlandsUnknown status
FrisiusMC
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LeeuwardenNetherlandsUnknown status
Maastricht UMC
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MaastrichtNetherlandsUnknown status
Antonius Hospital
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NieuwegeinNetherlandsUnknown status
Jeroen Bosch Ziekenhuis
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's-HertogenboschNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.