Predicting Heart Weakening in People Receiving Pacemakers and Similar Heart Devices
Builds a risk score for heart weakening in people receiving pacemakers.
Key facts
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Where
- Baden, Bern, and Geneva, SwitzerlandSee the 3 sitesAlso in 6 other countries, 10 sites
- Trial code
- Registry title
- Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
- Status
- Recruiting
- People taking part
- 4,500 people, planned
- Started
- 1 Jan 2026
- Expected to end
- 1 Jan 2031
- Type of study
- Observational
- Record updated
- 11 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are getting, or already had, a pacemaker, ICD or CRT heart device. It follows them to learn who is at risk of heart weakening from pacing.
- Age
- 18 years or older at the time of the device procedure
- Sex
- All
- Disease stage
- People having, or who have had, a permanent pacemaker, ICD or CRT device procedure
Main reasons for not taking part
- Prospective arm only: severe cognitive impairment without a legal representative
- A documented objection to the use of health data for research
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Age ≥18 years at the time of the CIED procedure
- Undergoing, or having undergone, a CIED procedure (permanent pacemaker, ICD, or CRT)
- A lawful basis for inclusion: signed informed consent prior to enrollment in the prospective arm, or a lawful basis for the further use of health-related personal data in the retrospective arm
- 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
Who cannot take part
- Prospective arm only: severe cognitive impairment without a legal representative
- A documented objection to the use of health-related data for research
Where in Switzerland
Also in 6 other countries, 10 sites
- Kantonsspital BadenBaden, SwitzerlandContact: Nikola A. Kozhuharov, PD Dr. med.Not yet recruiting
- Inselspital, University Hospital BernBern, SwitzerlandContact: Nikola A. Kozhuharov, PD Dr. med.Taking people
- Hôpitaux universitaires de GenèveGeneva, SwitzerlandContact: Nikola A. Kozhuharov, PD Dr. med.Not yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
- Plain-language title
- Predicting Heart Weakening in People Receiving Pacemakers and Similar Heart DevicesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 September 2026