Status:
TERMINATED
MOnitoring REsynchronization deviCes and cARdiac patiEnts
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices 1. Remote monitoring with Car...
Detailed Description
Major cardiovascular adverse events in patients with heart failure treated with cardiac resynchronization therapy (CRT-D) represent a big concern to the medical community, as they require hospitalizat...
Eligibility Criteria
Inclusion
- Patient indicated to CRT-ICD according to current guidelines:
- Left ventricular systolic dysfunction (LVEF≤35%),
- New York Heart Association functional class III-IV,
- QRS≥120 ms
- Optimized medical treatment.
- Patient implanted within the last 8 weeks with Medtronic CRT-ICD device equipped with fluid accumulation diagnostics, AT/AF monitoring capability, wireless telemetry for automatic remote data transmission and alerting system for physician.
- Patient with less than 8 weeks follow-up, who has not received Carelink® Network Monitor and was not managed by Cardiac Compass report reviewing.
- Carelink Network is available at patient's home
- Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties.
- Patient is willing and able to sign an informed consent form.
Exclusion
- Inability to fully understand the instructions relating to remote monitoring using CareLink® Network.
- Permanent AT/AF.
- Patient had not been previously implanted with a CRT/CRT-D device.
- Patient has medical conditions that would limit study participation.
- Patient is less than 18 years of age.
- Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints.
- Patient meets any exclusion criteria required by local law.
- Inability or refusal to sign a patient informed consent form.
- Patient's life expectancy is less than one year in the opinion of the physician
- Patient is pregnant or breastfeeding.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
918 Patients enrolled
Trial Details
Trial ID
NCT00885677
Start Date
June 1 2009
End Date
January 1 2016
Last Update
July 2 2025
Active Locations (64)
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1
Institut Klinicke a Experimentalni Mediciny
Prague, Czechia
2
Centre Hospitalier Universitaire de Angers
Angers, France
3
Hôpital Cardiologique du Haut Lévêque
Bordeaux, France
4
Centre Hospitalier
La Rochelle, France