Arrhythmias, Cardiac, Cardiomyopathy, Secondary, Conduction System Pacing, Heart Failure, Pacing Induced Cardiomyopathy
Conditions
Brief 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.
Interventions
None listed
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | up to 10 years after the CIED procedure |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants who died from any cause on follow-up | up to 10 years after the CIED procedure |
| Number of participants hospitalized for heart failure on follow-up | up to 10 years after the CIED procedure |
| Number of participants hospitalized for other cardiovascular events (excluding heart failure) on follow-up | up to 10 years after the CIED procedure |
| Number of participants hospitalized for non-cardiovascular reasons on follow-up | up to 10 years after the CIED procedure |
| Number of participants undergoing upgrade to CRT on follow-up | up to 10 years after the CIED procedure |
| Number of participants with device-related complications on follow-up | 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) | 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) | 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 | 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 | up to 10 years after the CIED procedure |
| Inter-center and inter-country variation in CIED practice, including percentage of patients receiving CSP | up to 10 years after the CIED procedure |
| Average percentage of ventricular pacing on follow-up | up to 10 years after the CIED procedure |
| Number of participants with device-detected subclinical atrial fibrillation on follow-up | up to 10 years after the CIED procedure |
| Number of participants experiencing stroke, stratified by modified Rankin Score on follow-up | up to 10 years after the CIED procedure |
| Number of participants with moderate or severe tricuspid valve regurgitation on echocardiography on follow-up | up to 10 years after the CIED procedure |
Countries
Australia, Bulgaria, Croatia, Cyprus, Germany, Poland, Switzerland
Contacts
CONTACTNikola A. Kozhuharov, PD Dr. med.
PRINCIPAL_INVESTIGATORNikola A. Kozhuharov, PD Dr. med.
Inselspital, University Hospital Bern, Clinic of Cardiology
Outcome results
None listed