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

Recruitingn/aAges 18 Years - anyAllInsel Gruppe AG, University Hospital Bern
NCT07276139 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, incl

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

13 sites
Canberra Health Services
Canberra, Australia
Acibadem City Clinic Tokuda Hospital
Sofia, Bulgaria
University Hospital Tsaritsa Yoanna ISUL
Sofia, Bulgaria
Dubrava University Hospital
Zagreb, Croatia
Nicosia General Hospital
Nicosia, Cyprus
University Heart Center Freiburg-Bad Krozingen
Bad Krozingen, Germany
Clinical Provincial Hospital No. 2
Rzeszów, Poland
National Institute of Cardiology
Warsaw, Poland

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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