Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation

NCT07852221 | Recruiting

• 4 other identifiers: 2019-0115140793146432019
• Study Type: observational
• Target: 2,600
• Locations: 3 countries
• Sites: 5

Brief Summary

Atrioventricular node ablation with permanent pacing (the "pace-and-ablate" strategy) controls ventricular rate in atrial fibrillation that has not responded to drug therapy or catheter ablation. Chronic right ventricular pacing, however, can cause pacing-induced cardiomyopathy (PICM), and it is not well established which patients are at risk and should therefore receive conduction system pacing or biventricular pacing instead. REPACE is a multicentre retrospective cohort of consecutive patients who underwent atrioventricular node ablation from January 2011 onwards at five centres in Switzerland, the United Kingdom and Poland: Liverpool Heart and Chest Hospital, Inselspital Bern, University Hospital Basel, Geneva University Hospitals and the Silesian Centre for Heart Diseases, Zabrze. More than 2,000 patients ablated up to March 2024 have been included to date; patients ablated after that date at the participating centres are being added. The study has three aims: to validate, in an independent multicentre population, a previously published risk model for pacing-induced cardiomyopathy; to describe the procedural technique and outcomes of atrioventricular node ablation across different health systems; and to estimate the health-economic impact of the pace-and-ablate strategy. Pacing-induced cardiomyopathy is defined as an absolute reduction in left ventricular ejection fraction of at least 10 percentage points to a value below 50%. All potential endpoints are adjudicated by a clinical events committee blinded to the classification made at the site.

Conditions

Atrial Fibrillation (AF); Cardiomyopathy, Secondary; Pacing-Induced Cardiomyopathy; Heart Failure

Keywords

Pace-and-ablate; Atrioventricular node ablation; Conduction system pacing

Outcome Measures

Primary Outcomes (1)

• Incidence of pacing-induced cardiomyopathy (PICM)

  Proportion of patients who develop PICM, defined as an absolute reduction in left ventricular ejection fraction (LVEF) of at least 10 percentage points to a value below 50% on echocardiography after atrioventricular node ablation with ventricular pacing. Each potential event is adjudicated by two independent reviewers blinded to the classification made at the site, with a third reviewer consulted in case of disagreement.

  From atrioventricular node ablation up to 10 years

Secondary Outcomes (11)

• All-cause mortality by pacing modality

  From atrioventricular node ablation up to 5 years

• Heart failure hospitalisation by pacing modality

  From atrioventricular node ablation up to 5 years

• Acute procedural success of atrioventricular node ablation

  Periprocedural (index atrioventricular node ablation)

• Use of a second ablation catheter, by type of first ablation catheter (irrigated versus non-irrigated)

  Periprocedural (index atrioventricular node ablation)

• Presence of a ventricular escape rhythm after atrioventricular node ablation

  Periprocedural (index atrioventricular node ablation)

Study Arms (1)

Pace-and-ablate cohort

Consecutive adults with atrial fibrillation who underwent atrioventricular node ablation with a permanent cardiac implantable electronic device at the five participating centres from January 2011 onwards. Within this cohort, the patients who had neither cardiac resynchronisation therapy nor conduction system pacing at baseline form the population for the validation of the pacing-induced cardiomyopathy risk model.

Eligibility Criteria

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

Study Population

Consecutive adults with symptomatic atrial fibrillation refractory to drug therapy or catheter ablation who underwent atrioventricular node ablation as part of a pace-and-ablate strategy at five participating centres in Switzerland, the United Kingdom and Poland from January 2011 onwards. Retrospective inclusion is covered by general consent to the further use of health-related data where this is on file. For deceased or uncontactable patients with no documented refusal, inclusion is covered by the exception from consent under Article 34 of the Swiss Human Research Act (Absence of informed consent), the project having been approved by the Kantonale Ethikkommission Bern. The United Kingdom site operates under IRAS 314643.

You may qualify if:

• Age 18 years or older at the time of atrioventricular node ablation
• Atrial fibrillation, undergoing atrioventricular node ablation with a permanent cardiac implantable electronic device already in situ or implanted as part of the pace-and-ablate strategy
• Availability of baseline echocardiographic data, including left ventricular ejection fraction

You may not qualify if:

• \* Documented refusal of the further use of health-related data

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• University Hospital, Basel, Switzerland: collaborator
• University Hospital, Geneva: collaborator
• Silesian Centre for Heart Diseases, Zabrze: collaborator
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator

Study Sites (5)

Silesian Centre for Heart Diseases

Zabrze, 41-800, Poland

RECRUITING

Inselspital, Universitätsspital Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

RECRUITING

Related Publications (1)

• Kozhuharov N, Gstoehl AM, Calvert P, Koniari I, Najm A, Mills MT, Thu K, Xydis P, Usteri R, Babinska A, Haeberlin A, Reichlin T, Sticherling C, Burri H, Wright DJ, Rao A, Gupta D. Predictors of pacing-induced cardiomyopathy in patients undergoing AV nodal ablation: insights from a Delphi process and retrospective cohort study. Eur Heart J Open. 2026 Jun 29;6(3):oeag102. doi: 10.1093/ehjopen/oeag102. eCollection 2026 May.

  PMID: 42375855 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Nikola A Kozhuharov, PD Dr. med.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikola A Kozhuharov, PD Dr. med.

CONTACT

+41 76 443 90 86; nikola.kozhuharov@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: October 1, 2026
• Study Start: January 5, 2011
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

GB (1); PL (1); CH (3)