Cardiovascular Diseases (CVD)EVIDENCE-RM 2NCT07881250
EValuation of prognostIc and Cost reDuction by tElemonitoring iN CIEDs Usual carE: an Updated Analysis Using 2019-2023 Data
An observational study of Cardiovascular Diseases (CVD) and Cardiac Implantable Electronic Device (CIED), run by Implicity at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases (CVD), Cardiac Implantable Electronic Device (CIED)
- What is being tested?
- No RM exposure, RM exposure and Conventional RM
- Type of treatment
- Medical device
- How many people
- 100,000 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2026to 15 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Overall Population: RM vs. no RM
- Remote Monitoring Population: patients who initiated RM within one year of implantation, compared by RM solution (Implicity universal platform vs. conventional manufacturer-specific platforms).
- Being tested
- No RM exposure, RM exposure, Conventional RM, Implicity RM
- Keywords
- Remote Monitoring
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No RM exposureOther
Person-time contributed before RM initiation, or throughout follow-up for patients who never initiated RM
RM exposureDevice
Person-time contributed after RM initiation, or throughout follow-up for patients already receiving RM at cohort entry
Conventional RMDevice
Patients followed remotely through manufacturer-specific platforms
Implicity RMDevice
Patients followed through the universal Implicity platform
| Study group | Role | What they receive |
|---|---|---|
| Overall Population | * 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 Receives: Other: No RM exposure; Device: RM exposure | |
| Remote Monitoring Population | * Conventional RM: patients followed remotely through manufacturer-specific platforms
* Implicity RM: patients followed through the universal Implicity platform Receives: Device: Conventional RM; Device: Implicity RM |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Up to 5 years
Secondary outcomes (11)
Number of all-cause hospitalizations (events per patient-year)
Measured: Up to 5 years
Number of hospitalizations related to heart failure (HF) (events per patient-year)
Measured: Up to 5 years
Number of hospitalizations related to stroke (events per patient-year)
Measured: Up to 5 years
Number of hospitalizations related to acute myocardial infarction (events per patient-year)
Measured: Up to 5 years
Cumulated duration of hospitalization (days)
Measured: Up to 5 years
Cumulated duration of hospitalization related to HF (days)
Measured: Up to 5 years
Cumulated duration of hospitalization related to stroke (days)
Measured: Up to 5 years
Cumulated duration of hospitalization for acute myocardial infarction (days)
Measured: Up to 5 years
Total direct healthcare costs
Measured: Up to 5 years
Days Alive and Out of Hospital (DAOH)
Measured: Up to 5 years
Incremental Cost-Effectiveness Ratio (ICER)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start7 Oct 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implicity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881250
- Sponsor's protocol ID
- EVIDENCE-RM_02
- Acronym
- EVIDENCE-RM 2
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No