About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
All-cause mortality by pacing modality
Proportion of patients who die from any cause, reported separately for right ventricular pacing, biventricular pacing and conduction system pacing.
Heart failure hospitalisation by pacing modality
Proportion of patients with at least one hospitalisation for heart failure, reported separately for right ventricular pacing, biventricular pacing and conduction system pacing.
Acute procedural success of atrioventricular node ablation
Proportion of procedures with complete atrioventricular block at the end of the procedure, i.e. intended loss of atrioventricular conduction with transition to ventricular pacing.
Use of a second ablation catheter, by type of first ablation catheter (irrigated versus non-irrigated)
Proportion of procedures in which a second ablation catheter was required to achieve atrioventricular block, reported separately for procedures started with an irrigated and with a non-irrigated catheter.
Sponsors and contacts
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
University of Bern
Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborator
University Hospital, Basel, Switzerland
Collaborator
University Hospital, Geneva
Collaborator
Silesian Centre for Heart Diseases, Zabrze
Collaborator