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

NCT07852221 · tracked via the Priya Life Science Poland tracker

Sponsor

Insel Gruppe AG, University Hospital Bern

Phase

Observational

Started

2011-01-05

Last updated

2026-10-01

Condition(s) studied

Atrial Fibrillation (AF)Cardiomyopathy, SecondaryPacing-Induced CardiomyopathyHeart Failure

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: \* Documented refusal of the further use of health-related data Note: cardiac resynchronisation therapy or conduction system pacing at baseline is not an eligibility exclusion. Such patients are included in the cohort and in the procedural and health-economic analyses, but are excluded from the validation of the pacing-induced cardiomyopathy risk model, in which a decline in left ventricular function would represent non-response to resynchronisation. No lower limit of baseline ejection fraction is applied.

Primary outcome measure(s)

Incidence of pacing-induced cardiomyopathy (PICM) — From atrioventricular node ablation up to 10 years
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.

Trial sites (5)

Facility	City	Region	Status
Silesian Centre for Heart Diseases	Zabrze	Poland	Recruiting
Inselspital, Universitätsspital Bern	Bern	Canton of Bern	Recruiting
University Hospital Basel	Basel	Switzerland	Recruiting
Geneva University Hospitals	Geneva	Switzerland	Recruiting
Liverpool Heart and Chest Hospital	Liverpool	Merseyside	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07852221 on ClinicalTrials.gov ↗ ← All trials in Poland