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Heart Failure / Arrhythmias, Cardiac / Cardiomyopathy, Secondary · Observational Study
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned international observational cohort study, not yet reporting outcomes, designed to develop and validate a predictive model for pacing-induced cardiomyopathy risk in patients receiving cardiac implantable electronic devices. The study combines prospective enrollment at device implantation with retrospective data from treated patients, with planned follow-up to 10 years and comparison of pacing strategies across healthcare systems. No clinical results or effect estimates are available; this record describes the protocol and study structure only.
Observational. Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing; age from 18 Years. Intervention: Cardiac implantable electronic device implantation with varied pacing strategies including conduction system pacing and CRT.. Compared with: Comparison of clinical practices and cost-effectiveness across different pacing strategies and healthcare systems; development of risk prediction model to guide personalized strategies.. n = 4,500. 13 sites across 7 countries.
This is a planned international observational cohort study, not yet reporting outcomes, designed to develop and validate a predictive model for pacing-induced cardiomyopathy risk in patients receiving cardiac implantable electronic devices. The study combines prospective enrollment at device implantation with retrospective data from treated patients, with planned follow-up to 10 years and comparison of pacing strategies across healthcare systems. No clinical results or effect estimates are available; this record describes the protocol and study structure only.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a registry record for an ongoing observational study with no results reported; recruitment is active and follow-up extends to 10 years, so evidence generation is not yet complete.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07276139). This is a study registration, not published results. Lead sponsor: Insel Gruppe AG, University Hospital Bern. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 4500 participants (ESTIMATED). Conditions: Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing. Primary outcome measures: Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to <50% during follow-up after a CIED procedure , up to 10 years after the CIED procedure. Brief summary: The PACEVALUE study is a large, international observational study aiming to improve the treatment of patients receiving cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. While these devices are vital for managing heart rhythm disorders and heart failure, chronic right ventricular pacing can sometimes cause a condition called pacing-induced cardiomyopathy (PICM), where the left side of the heart weakens over time, leading to increased hospitalizations and higher mortality. The main goal of the study is to develop and validate a risk prediction model using routine clinical and device data to identify patients at highest risk of PICM before device implantation. By stratifying patients according to this risk score, the study aims to guide personalized pacing strategies, including conduction system pacing (CSP) and CRT options, to improve outcomes and reduce complications. The study will include approximately 4,500 patients across centers in Switzerland, Germany, Poland, Croatia, Bulgaria, Cyprus, and Australia, with planned inclusion of sites in the UK. Patients are included in two arms. In the prospective arm, consecutive patients are enrolled at the time of their device procedure. In the retrospective arm, centers include patients they have already treated, using data already recorded during clinical care. Both arms use the same case report form and the same endpoint definitions. Participants are followed annually for up to ten years, with data collection including heart function imaging, device data, clinical outcomes, patient-reported outcomes (PROMs/PREMs), and healthcare costs. This observational study will also compare clinical practices and cost-effectiveness of different pacing strategies across diverse healthcare systems, aiming to inform evidence-based, patient-centered, and economically efficient device therapy decisions. The findings will lay the groundwork for future registry-based randomized controlled trials to further optimize pacing treatments.
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