An observational study in Cardiomyopathy, Secondary, Arrhythmias, Cardiac and Heart Failure, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
553 studies on the registry are indexed under Cardiomyopathies; 152 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 200 across 263 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes adults undergoing a cardiac implantable electronic device (CIED) procedure for standard clinical indications, included in two arms. In the prospective arm, consecutive patients at a participating center are enrolled at the time of the procedure. In the retrospective arm, centers include all consecutive patients who underwent a CIED procedure from a center-specific start date up to the date of data extraction, using data already recorded during clinical care. Participants are drawn from centers in Switzerland, Germany, Poland, Croatia, Bulgaria, Cyprus, and Australia, with planned activation of sites in the UK. The population includes patients receiving pacemakers, ICDs, or CRT devices; patients with existing CRT at baseline serve as a comparator. Both arms use the same case report form and the same endpoint definitions. Enrollment reflects diverse healthcare settings and demographics.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: up to 10 years after the CIED procedure
Number of participants who died from any cause on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for heart failure on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for other cardiovascular events (excluding heart failure) on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for non-cardiovascular reasons on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants undergoing upgrade to CRT on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with device-related complications on follow-up
Time frame: up to 10 years after the CIED procedure
Change in EQ-5D-5L Index Score from Baseline (range 0-1; higher scores indicate better quality of life)
Time frame: at Baseline, 8 weeks, and annually to year 10
Change in patient satisfaction score with remote monitoring from Baseline (range 0-10; higher scores indicate higher satisfaction)
Time frame: Baseline, 8 weeks, and annually to year 10
Total healthcare costs per patient for CSP versus right ventricular pacing, applying the PICM risk prediction score
Time frame: up to 10 years after the CIED procedure
Incremental cost-effectiveness ratio (ICER) of CSP versus right ventricular pacing per quality-adjusted life year (QALY) gained, applying the PICM risk prediction score
Time frame: up to 10 years after the CIED procedure
Inter-center and inter-country variation in CIED practice, including percentage of patients receiving CSP
Time frame: up to 10 years after the CIED procedure
Average percentage of ventricular pacing on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with device-detected subclinical atrial fibrillation on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants experiencing stroke, stratified by modified Rankin Score on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with moderate or severe tricuspid valve regurgitation on echocardiography on follow-up
Time frame: up to 10 years after the CIED procedure
Plan to share: No — Individual participant data will not be shared. The prediction model is published in full, including every coefficient, the baseline risk at each prediction horizon, the shrinkage applied and the functional forms, in sufficient detail for a predicted risk to be computed without contacting the investigators. Analyses are conducted within the collaboration under the applicable agreements and reported according to TRIPOD+AI.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Insel Gruppe AG, University Hospital Bern →