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

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.

Eligibility

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

Conditions6

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