Ireland
--:--IST
Active, not recruiting Observational

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

NCT07881250 · tracked via the Priya Life Science France tracker
Sponsor
Implicity
Phase
Observational
Started
2026-10-07
Last updated
2026-10-19

Condition(s) studied

Cardiovascular Diseases (CVD)Cardiac Implantable Electronic Device (CIED)

Investigational drug(s) / intervention(s)

No RM exposureRM exposureConventional RMImplicity RM

No RM exposure: Person-time contributed before RM initiation, or throughout follow-up for patients who never initiated RM

RM exposure: Person-time contributed after RM initiation, or throughout follow-up for patients already receiving RM at cohort entry

Conventional RM: Patients followed remotely through manufacturer-specific platforms

Implicity RM: Patients followed through the universal Implicity platform

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • All-cause mortality — Up to 5 years

Trial sites (1)

FacilityCityRegionStatus
Implicity Paris France

More Implicity trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07881250 on ClinicalTrials.gov ↗ ← All trials in France