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Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy

NCT03012490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2026-02-05

No results posted yet for this study

Summary

The primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.

Conditions

Interventions

OTHER

CRT-P or CRT-D standard remote monitoring

standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system

OTHER

CRT-P or CRT-D full remote monitoring

Full follow-up for the Active group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system + supraventricular rhythm disorders, parameters related to heart failure, including symptoms and clinical signs of the patient

OTHER

Symptoms and signs remote monitoring

symptoms and clinical signs of the patient

Sponsors & Collaborators

  • Biotronik France

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Laurence Guedon-Moreau, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2020-06-09
Completion
2020-06-09

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012490 on ClinicalTrials.gov