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.
Study Type
OBSERVATIONAL
Enrollment
4,500
Canberra Health Services
Canberra, Australian Capital Territory, Australia
RECRUITINGAcibadem City Clinic Tokuda Hospital
Sofia, Bulgaria
NOT_YET_RECRUITINGUniversity Hospital Tsaritsa Yoanna ISUL
Sofia, Bulgaria
NOT_YET_RECRUITINGDubrava University Hospital
Zagreb, Croatia
NOT_YET_RECRUITINGNicosia General Hospital
Nicosia, Cyprus
NOT_YET_RECRUITINGUniversity Heart Center Freiburg-Bad Krozingen
Bad Krozingen, Germany
NOT_YET_RECRUITINGClinical Provincial Hospital No. 2
Rzeszów, Poland
NOT_YET_RECRUITINGNational Institute of Cardiology
Warsaw, Poland
NOT_YET_RECRUITING4th Military Clinical Hospital
Wroclaw, Poland
NOT_YET_RECRUITINGMedical University of Silesia
Zabrze, Poland
NOT_YET_RECRUITING...and 3 more locations
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
Time frame: up to 10 years after the CIED procedure
Number of participants who died from any cause on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for heart failure on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for other cardiovascular events (excluding heart failure) on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for non-cardiovascular reasons on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants undergoing upgrade to CRT on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with device-related complications on follow-up
Time frame: up to 10 years after the CIED procedure
Change in EQ-5D-5L Index Score from Baseline (range 0-1; higher scores indicate better quality of life)
Time frame: at Baseline, 8 weeks, and annually to year 10
Change in patient satisfaction score with remote monitoring from Baseline (range 0-10; higher scores indicate higher satisfaction)
Time frame: Baseline, 8 weeks, and annually to year 10
Total healthcare costs per patient for CSP versus right ventricular pacing, applying the PICM risk prediction score
Time frame: up to 10 years after the CIED procedure
Incremental cost-effectiveness ratio (ICER) of CSP versus right ventricular pacing per quality-adjusted life year (QALY) gained, applying the PICM risk prediction score
Time frame: up to 10 years after the CIED procedure
Inter-center and inter-country variation in CIED practice, including percentage of patients receiving CSP
Time frame: up to 10 years after the CIED procedure
Average percentage of ventricular pacing on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with device-detected subclinical atrial fibrillation on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants experiencing stroke, stratified by modified Rankin Score on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with moderate or severe tricuspid valve regurgitation on echocardiography on follow-up
Time frame: up to 10 years after the CIED procedure
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