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Active Not Recruiting NCT07881250

EValuation of prognostIc and Cost reDuction by tElemonitoring iN CIEDs Usual carE: an Updated Analysis Using 2019-2023 Data

Conditions: Cardiovascular Diseases (CVD), Cardiac Implantable Electronic Device (CIED)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100000
Sponsor: Implicity

Location: Implicity Paris

Summary

The EVIDENCE-RM study is a nationwide, non-interventional retrospective study evaluating the clinical and medico-economic impact of remote monitoring (RM) in patients with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Using data from the French national health database (SNDS) between 2019 and 2023, the study compares clinical outcomes and healthcare costs between patients with and without RM, as well as between those monitored via the universal Implicity platform versus conventional manufacturer-specific solutions.

Eligibility Criteria

Inclusion Criteria: * Aged ≥ 18 years and alive on January 1, 2019 * Implanted with an ICD or CRT-D between January 1, 2010, and December 31, 2023 according to 2022 ESC guidelines Exclusion Criteria: * Device upgrade (eg. ICD to CRT-D or PM to ICD/CRT-D or CRT-P to CRT-D) * Discontinuation of remote monitoring during follow-up * Initiation of remote monitoring \>1 year device post-implantation * For the Remote Monitoring cohort only: Crossover between the universal Implicity platform and a conventional manufacturer specific monitoring system (Carelink for Medtronic, Latitude for Boston Scientific, Home Monitoring for Biotronik, Merlin for Abbott, Smartview for MicroPort) during follow-up and conversely

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07881250). StuddyBuddy aggregates publicly available trial information.