An observational study in Cardiovascular Diseases (CVD) and Cardiac Implantable Electronic Device (CIED), sponsored by Implicity. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Implicity · Observational
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.
EVIDENCE-RM 2 updates the initial nationwide EVIDENCE-RM study (Varma et al., 2025) over an extended 2019-2023 period in a larger population of ICD and CRT-D recipients, using data from the French National Health Data System (SNDS) linked with the Implicity database.
Two populations are analyzed:
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 600 across 1,524 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Implicity is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of all patients aged 18 years or older, alive on January 1, 2019, and implanted with an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) in France between January 1, 2010, and December 31, 2023. Data are extracted from the French National Health Data System (SNDS). The population comprises both patients receiving remote monitoring (via the Implicity platform or manufacturer-specific solutions) and patients receiving no remote monitoring.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
* 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
Other: No RM exposure · Device: RM exposure
* Conventional RM: patients followed remotely through manufacturer-specific platforms * Implicity RM: patients followed through the universal Implicity platform
Device: Conventional RM · Device: Implicity RM
Person-time contributed before RM initiation, or throughout follow-up for patients who never initiated RM
Person-time contributed after RM initiation, or throughout follow-up for patients already receiving RM at cohort entry
Patients followed remotely through manufacturer-specific platforms
Patients followed through the universal Implicity platform
All-cause mortality
Time frame: Up to 5 years
Number of all-cause hospitalizations (events per patient-year)
Time frame: Up to 5 years
Number of hospitalizations related to heart failure (HF) (events per patient-year)
Time frame: Up to 5 years
Number of hospitalizations related to stroke (events per patient-year)
Time frame: Up to 5 years
Number of hospitalizations related to acute myocardial infarction (events per patient-year)
Time frame: Up to 5 years
Cumulated duration of hospitalization (days)
Time frame: Up to 5 years
Cumulated duration of hospitalization related to HF (days)
Time frame: Up to 5 years
Cumulated duration of hospitalization related to stroke (days)
Time frame: Up to 5 years
Cumulated duration of hospitalization for acute myocardial infarction (days)
Time frame: Up to 5 years
Total direct healthcare costs
Time frame: Up to 5 years
Days Alive and Out of Hospital (DAOH)
Time frame: Up to 5 years
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: Up to 5 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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