Atrial Fibrillation (AF)REPACENCT07852221
Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation
An observational study of Atrial Fibrillation (AF) and Cardiomyopathy, Secondary, run by Insel Gruppe AG, University Hospital Bern at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Cardiomyopathy, Secondary, Pacing-Induced Cardiomyopathy
- How many people
- 2,600 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 5 Jan 2011to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Christian Sticherling, MD
- Recruiting
Inselspital, Universitätsspital Bern
Bern, Canton of Bern, 3010
Nikola A Kozhuharov, PD Dr. med., nikola.kozhuharov@insel.ch
Nikola A Kozhuharov, PD Dr. med.
- Recruiting
Geneva University Hospitals
Geneva, 1205
Haran Burri, MD
Poland1 site, 1 recruiting
- Recruiting
Silesian Centre for Heart Diseases
Zabrze, 41-800
Agnieszka Babińska, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, L14 3PE
Dhiraj Gupta, MD, FRCP, Dhiraj.Gupta@lhch.nhs.uk
Dhiraj Gupta, MD, FRCP
About this study
Official title: Patient Selection and Long-Term Outcomes in Patients With a Pace & Ablate Strategy for Interventional Rate Control in Symptomatic Permanent Atrial Fibrillation - A Retrospective Multicenter Analysis
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.
Read more
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.
Read the detailed description
Data collection. Baseline demographics, comorbidity, device and procedural data, electrocardiographic and echocardiographic measurements, follow-up events and mortality were abstracted from hospital records at each participating centre into a central electronic case report form.
Endpoint adjudication. Every potential endpoint is reviewed by two independent adjudicators blinded to the classification made at the site, with a third reviewer consulted where they disagree. Pacing-induced cardiomyopathy is assessed on every adjudicated event, independently of how that event is otherwise classified.
Analysis populations. The validation of the risk model is performed in the patients who had neither cardiac resynchronisation therapy nor conduction system pacing at baseline, because a decline in left ventricular function in an already resynchronised patient represents non-response to resynchronisation rather than pacing-induced cardiomyopathy. Patients with resynchronisation at baseline are described and contribute to the procedural and health-economic analyses. No lower limit of baseline ejection fraction is applied: since the definition requires a fall of at least 10 percentage points to a value below 50%, patients already below 50% at baseline can meet it.
Health-economic analysis. Direct costs are derived from Hospital Episode Statistics in the United Kingdom, individual procedure costs from the SwissEPnet registry for Switzerland, and diagnosis-related group and hospital costs for Switzerland and Poland, covering hospital charges, device costs and subsequent care for complications and follow-up. Cost-utility and cost-effectiveness analyses use Markov models to compare pacing strategies.
- Conditions
- Atrial Fibrillation (AF), Cardiomyopathy, Secondary, Pacing-Induced Cardiomyopathy, Heart Failure
- Keywords
- Pace-and-ablate, Atrioventricular node ablation, Conduction system pacing
- Medical subject headings
- Atrial Fibrillation, Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From atrioventricular node ablation up to 10 years
Secondary outcomes (11)
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.
Measured: From atrioventricular node ablation up to 5 years
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.
Measured: From atrioventricular node ablation up to 5 years
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.
Measured: Periprocedural (index atrioventricular node ablation)
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.
Measured: Periprocedural (index atrioventricular node ablation)
Presence of a ventricular escape rhythm after atrioventricular node ablation
Proportion of patients with a ventricular escape rhythm documented at the end of the atrioventricular node ablation procedure.
Measured: Periprocedural (index atrioventricular node ablation)
Procedure duration by use of a long sheath
Duration of the atrioventricular node ablation procedure in minutes, reported separately for procedures performed with and without a long sheath.
Measured: Periprocedural (index atrioventricular node ablation)
Cumulative direct healthcare costs per patient
Cumulative direct healthcare costs per patient in euros, covering the index procedure (hospital stay, device and consumables) and subsequent hospital care for complications and follow-up. Costs are derived from Hospital Episode Statistics (United Kingdom), the SwissEPnet registry and diagnosis-related group data (Switzerland, Poland) and converted to euros.
Measured: From atrioventricular node ablation up to 5 years
Incremental cost-effectiveness ratio of conduction system pacing versus right ventricular pacing
Incremental cost per quality-adjusted life-year (QALY) gained, estimated with a Markov model from the observed event rates and direct healthcare costs, overall and across strata of predicted pacing-induced cardiomyopathy risk and of procedural complexity.
Measured: From atrioventricular node ablation up to 5 years
Return to sinus rhythm during follow-up
Proportion of patients with documented return to sinus rhythm on electrocardiogram or device interrogation after atrioventricular node ablation.
Measured: From atrioventricular node ablation up to 5 years
Discrimination of the published and of an updated pacing-induced cardiomyopathy risk model (C-statistic)
C-statistic (area under the receiver operating characteristic curve) for predicting pacing-induced cardiomyopathy, reported for the previously published risk model as originally specified and for a model updated in this cohort (recalibration and re-estimation of predictor weights, with candidate additional predictors), in patients without cardiac resynchronisation therapy or conduction system pacing at baseline.
Measured: From atrioventricular node ablation up to 10 years
Incremental cost-effectiveness ratio of biventricular pacing versus right ventricular pacing
Incremental cost per quality-adjusted life-year (QALY) gained, estimated with a Markov model from the observed event rates and direct healthcare costs, overall and across strata of predicted pacing-induced cardiomyopathy risk and of procedural complexity.
Measured: From atrioventricular node ablation up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start5 Jan 2011
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Liverpool Heart and Chest Hospital NHS Foundation Trust, University Hospital, Basel, Switzerland, University Hospital, Geneva, Silesian Centre for Heart Diseases, Zabrze
- Responsible party
- Sponsor
- Investigators
- Nikola A Kozhuharov, PD Dr. med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852221
- Sponsor's protocol ID
- 2019-01151
- Other IDs
- 4079, 314643, 2019
- Acronym
- REPACE
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42375855
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Selection and Long-Term Outcomes in Patients With a Pace & Ablate Strategy for Interventional Rate Control in Symptomatic Permanent Atrial Fibrillation - A Retrospective Multicenter Analysis
- ClinicalTrials.gov ID
- NCT07852221
- Acronym / sponsor ID
- REPACE / 2019-01151
- Conditions
- Atrial Fibrillation (AF), Cardiomyopathy, Secondary, Pacing-Induced Cardiomyopathy, Heart Failure
- Keywords
- Pace-and-ablate, Atrioventricular node ablation, Conduction system pacing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, Liverpool Heart and Chest Hospital NHS Foundation Trust, University Hospital, Basel, Switzerland, University Hospital, Geneva, Silesian Centre for Heart Diseases, Zabrze
- Study start
- 5 Jan 2011 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data collection. Baseline demographics, comorbidity, device and procedural data, electrocardiographic and echocardiographic measurements, follow-up events and mortality were abstracted from hospital records at each participating centre into a central electronic case report form.
Endpoint adjudication. Every potential endpoint is reviewed by two independent adjudicators blinded to the classification made at the site, with a third reviewer consulted where they disagree. Pacing-induced cardiomyopathy is assessed on every adjudicated event, independently of how that event is otherwise classified.
Analysis populations. The validation of the risk model is performed in the patients who had neither cardiac resynchronisation therapy nor conduction system pacing at baseline, because a decline in left ventricular function in an already resynchronised patient represents non-response to resynchronisation rather than pacing-induced cardiomyopathy. Patients with resynchronisation at baseline are described and contribute to the procedural and health-economic analyses. No lower limit of baseline ejection fraction is applied: since the definition requires a fall of at least 10 percentage points to a value below 50%, patients already below 50% at baseline can meet it.
Health-economic analysis. Direct costs are derived from Hospital Episode Statistics in the United Kingdom, individual procedure costs from the SwissEPnet registry for Switzerland, and diagnosis-related group and hospital costs for Switzerland and Poland, covering hospital charges, device costs and subsequent care for complications and follow-up. Cost-utility and cost-effectiveness analyses use Markov models to compare pacing strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of pacing-induced cardiomyopathy (PICM)
Time frame: 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.
11 secondary outcomes
All-cause mortality by pacing modality
Time frame: From atrioventricular node ablation up to 5 years
Heart failure hospitalisation by pacing modality
Time frame: From atrioventricular node ablation up to 5 years
Acute procedural success of atrioventricular node ablation
Time frame: Periprocedural (index atrioventricular node ablation)
Use of a second ablation catheter, by type of first ablation catheter (irrigated versus non-irrigated)
Time frame: Periprocedural (index atrioventricular node ablation)
Presence of a ventricular escape rhythm after atrioventricular node ablation
Time frame: Periprocedural (index atrioventricular node ablation)
Procedure duration by use of a long sheath
Time frame: Periprocedural (index atrioventricular node ablation)
Cumulative direct healthcare costs per patient
Time frame: From atrioventricular node ablation up to 5 years
Incremental cost-effectiveness ratio of conduction system pacing versus right ventricular pacing
Time frame: From atrioventricular node ablation up to 5 years
Return to sinus rhythm during follow-up
Time frame: From atrioventricular node ablation up to 5 years
Discrimination of the published and of an updated pacing-induced cardiomyopathy risk model (C-statistic)
Time frame: From atrioventricular node ablation up to 10 years
Incremental cost-effectiveness ratio of biventricular pacing versus right ventricular pacing
Time frame: From atrioventricular node ablation up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 42375855Kozhuharov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikola A Kozhuharov, PD Dr. med. principal investigator
Insel Gruppe AG, University Hospital Bern
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Cardiomyopathy, Secondary, run by Insel Gruppe AG, University Hospital Bern at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikola A Kozhuharov, PD Dr. med. (+41 76 443 90 86, nikola.kozhuharov@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pacing-induced cardiomyopathy (PICM) (time frame: From atrioventricular node ablation up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.