AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation

NCT07604727 | Not Yet Recruiting DMC

• 1 other identifier: NL-011147
• Study Type: interventional
• Target: 292
• Locations: 4 countries
• Sites: 23

Brief 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.

Conditions

Atrial Fibrillation (AF); Heart Failure; Cardiac Pacing

Keywords

Conduction System Pacing; Cardiac Resynchronization; Atrial Fibrillation; AV Nodal Ablation; Heart Failure; All-cause Mortality; Quality of Life; HF hospitalization; Unplanned/urgent HF visit; Arterial Stiffness Index; Photoplethysmography; APAF-CSP; EQ-5D; AFEQT; Kansas City Cardiomyopathy Questionnaire (KCCQ)

Outcome Measures

Primary Outcomes (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.

  The Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition).

  From enrollment to the end of follow up (median follow-up of 2.5 years)

Secondary Outcomes (7)

• Major secondary endpoint: ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.

  From enrollment to the end of follow up (median follow-up of 2.5 years)

• Quality of Life Improvement (AFEQT Questionnaire)

  From enrollment to the end of follow up (median follow-up of 2.5 years)

• Quality of Life Improvement (EQ-5D-5L Questionnaire)

  From enrollment to the end of follow up (median follow-up of 2.5 years)

• HF Hospitalization or Unplanned/urgent HF Visit

  From enrollment to the end of follow up (median follow-up of 2.5 years)

• Cardiovascular Related Hospitalization

  From enrollment to the end of follow up (median follow-up of 2.5 years)

Other Outcomes (12)

• Duration of hospitalization for cardiovascular causes

  From enrollment to the end of follow up (median follow-up of 2.5 years)

• Clinical heart failure status (New York Heart Association (NYHA) Functional Classification)

  At baseline,1-year, and at end of follow-up (median of 2.5 years follow-up).

• Healthcare costs and cost-effectiveness parameters

  At the end of follow up (Median of 2.5 years follow up)

Study Arms (2)

CSP Group (Intervention Group)

OTHER

AV node ablation plus Conduction System Pacing implantation. CSP is established pacing strategy evaluated in comparison with CRT.

Procedure: Conduction System Pacing

CRT Group (Control Group)

ACTIVE COMPARATOR

AV node ablation plus cardiac resynchronization therapy implantation. CRT is established standard pacing strategy.

Procedure: Cardiac resynchronization therapy

Interventions

Conduction System Pacing PROCEDURE

The implantation of a pacing device with a pacing lead that aims to capture and pace the native conduction system.

CSP Group (Intervention Group)

Cardiac resynchronization therapy PROCEDURE

The implantation of a pacing device with a pacing leads that aims to capture and pace both ventricles in a synchronized fashion, to achieve the best possible hemodynamic parameters and synchrony.

CRT Group (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (23)

CHU de Grenoble

Grenoble, France

Location

CHU la Timone

Marseille, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

CHU de Rouen

Rouen, France

Location

Clinique Pasteur Toulouse

Toulouse, France

Location

Marienhospital Gelsenkirchen

Gelsenkirchen, Germany

Location

University Medical Center Mainz

Mainz, Germany

Location

Klinikum rechts der Isar

München, Germany

Location

St. Vincenz-Krankenhaus GmbH

Paderborn, Germany

Location

Klinik für Kardiologie und Intensivmedizin

Stade, Germany

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Location

Department of Cardiology, Ospedali del Tigullio

Lavagna, Italy

Location

Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Ospedale Santa Maria della Pieta

Nola, Italy

Location

Department of Cardiology, Ospedale S. Maria Nuova

Reggio Emilia, Italy

Location

Ospedale San Pietro Fatebenefratelli

Roma, Italy

Location

Department of Cardiology, Ospedale Panico

Tricase, Italy

Location

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

FrisiusMC

Leeuwarden, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

Antonius Hospital

Nieuwegein, Netherlands

Location

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MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Michiel Rienstra, MD, PhD, MHA, Professor

  University Medical Center Groningen, Groningen, The Netherlands

  STUDY CHAIR

• Yuri Blaauw, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michiel Rienstra, MD, PhD, MHA, Professor

CONTACT

+31503611327; m.rienstra@umcg.nl

Ahmed S Yassin, MD

CONTACT

a.s.e.m.yassin@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MHA, Professor of Clinical Cardiology

Model Details: The APAF-CSP trial is a prospective, multicenter, international, randomized, open-label, non-inferiority, parallel-arms trial

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

DE (5); IT (8); FR (5); NL (5)