PACEVALUE: Development of a Risk Score to Predict Pacing-Induced Cardiomyopathy in Patients Undergoing Pacemaker or ICD Implantation and Evaluation of Patient Outcomes and Cost-Effectiveness Across Different Healthcare Systems

NCT ID: NCT07276139

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 4500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2031-01-01

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 recruit approximately 4,500 patients across multiple centers in Europe and Australia, with planned future inclusion of sites in the UK. Participants will be followed for a minimum of two 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.

Conditions

Cardiomyopathy, Secondary; Arrhythmias, Cardiac; Heart Failure; Pacing Induced Cardiomyopathy; Conduction System Pacing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Signed informed consent prior to enrollment
• Age ≥18 years
• Undergoing a CIED implantation (permanent pacemaker, ICD, or CRT)
• Willing and able to participate in long-term follow-up
• Sufficient language comprehension (or support) to provide informed consent and complete PROMs/PREMs.

Exclusion Criteria

• Severe cognitive impairment without a legal representative

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikola A. Kozhuharov, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Inselspital, University Hospital Bern, Clinic of Cardiology

Locations

Inselspital, University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2025-02109

Identifier Type: -

Identifier Source: org_study_id