Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study

NCT07276139 | Recruiting

• 2 other identifiers: 2025-021092025
• Study Type: observational
• Target: 4,500
• Locations: 7 countries
• Sites: 13

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.

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 follow-up after a CIED procedure

  up to 10 years after the CIED procedure

Secondary Outcomes (15)

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

  up to 10 years after the CIED procedure

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

  up to 10 years after the CIED procedure

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

  up to 10 years after the CIED procedure

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

  up to 10 years after the CIED procedure

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

  up to 10 years after the CIED procedure

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 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.

You may qualify if:

• Age ≥18 years at the time of the CIED procedure
• Undergoing, or having undergone, a CIED procedure (permanent pacemaker, ICD, or CRT)
• Prospective arm only: willing and able to participate in long-term follow-up
• Prospective arm only: sufficient language comprehension (or support) to provide informed consent and complete PROMs/PREMs

You may not qualify if:

• Prospective arm only: severe cognitive impairment without a legal representative
• A documented objection to the use of health-related data for research

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (13)

Canberra Health Services

Canberra, Australian Capital Territory, Australia

RECRUITING

Acibadem City Clinic Tokuda Hospital

Sofia, Bulgaria

NOT YET RECRUITING

University Hospital Tsaritsa Yoanna ISUL

Sofia, Bulgaria

NOT YET RECRUITING

Dubrava University Hospital

Zagreb, Croatia

NOT YET RECRUITING

Nicosia General Hospital

Nicosia, Cyprus

NOT YET RECRUITING

University Heart Center Freiburg-Bad Krozingen

Bad Krozingen, Germany

NOT YET RECRUITING

Clinical Provincial Hospital No. 2

Rzeszów, Poland

NOT YET RECRUITING

National Institute of Cardiology

Warsaw, Poland

NOT YET RECRUITING

4th Military Clinical Hospital

Wroclaw, Poland

NOT YET RECRUITING

Medical University of Silesia

Zabrze, Poland

NOT YET RECRUITING

Kantonsspital Baden

Baden, Switzerland

NOT YET RECRUITING

Inselspital, University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, Switzerland

NOT YET RECRUITING

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

Central Study Contacts

Nikola A. Kozhuharov, PD Dr. med.

CONTACT

+41 31 63 2 36 50; nikola.kozhuharov@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 120 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, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3); BU (2); CY (1); CR (1); DE (1); PL (4); AU (1)