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

NCT07276139 | Active Not Recruiting

• 1 other identifier: 2025-02109
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to ≤50% during long-term follow-up after CIED implantation

  up to 2 years after device implantation

Secondary Outcomes (15)

• Number of participants who died from any cause on follow-up

  up to 5 years after device implantation

• Number of participants hospitalized for heart failure on follow-up

  up to 5 years after device implantation

• Number of participants hospitalized for other cardiovascular events (excluding heart failure) on follow-up

  up to 5 years after device implantation

• Number of participants hospitalized for non-cardiovascular reasons on follow-up

  up to 5 years after device implantation

• Number of participants undergoing upgrade to CRT on follow-up

  up to 5 years after device implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients undergoing CIED implantation for standard clinical indications. Participants are recruited from multiple international centers in Switzerland, Bulgaria, Croatia, Poland, Australia, and the UK. The population includes patients receiving pacemakers, ICDs, or CRT devices. Patients with existing CRT at baseline serve as a comparator. The study collects real-world clinical practice data, imaging, device parameters, and PROMs/PREMs during long-term follow-up. Enrollment reflects diverse healthcare settings and demographics.

You may qualify if:

• 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.

You may not qualify if:

• Severe cognitive impairment without a legal representative

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Cardiomyopathies; Arrhythmias, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikola A. Kozhuharov, PD Dr. med.

  Inselspital, University Hospital Bern, Clinic of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CH (1)