Pacing decisions guided by risk for pacing-induced heart muscle weakness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PACEVALUE is an international observational effort to use routinely collected clinical and device data to predict who is at highest risk of pacing-induced cardiomyopathy after device implantation. The study aims to help physicians personalize pacing strategies, including conduction system pacing and cardiac resynchronization therapy, to minimize complications and hospitalizations. It will develop and validate a risk model that can be applied in prospective patients and use retrospective data to support its performance. The initiative involves adults undergoing pacemakers, ICDs, or CRT devices and follows participants over time to observe outcomes related to heart function and device performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Where it's running

• Canberra Health Services
  Canberra, Australian Capital Territory, Australia Recruiting
• Inselspital, University Hospital Bern
  Bern, Switzerland 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

Study contacts

• Principal investigator: Nikola A. Kozhuharov, PD Dr. med. — Inselspital, University Hospital Bern, Clinic of Cardiology
• Study coordinator: Nikola A. Kozhuharov, PD Dr. med.
• Email: nikola.kozhuharov@insel.ch
• Phone: +41 31 63 2 36 50

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.