Overview

This trial is active, not recruiting.

Condition heart failure
Treatment medtronic crt insync® family devices
Phase phase 4
Sponsor Medtronic Bakken Research Center
Collaborator Medtronic
Start date September 2006
End date July 2010
Trial size 550 participants
Trial identifier NCT00318357, CARE-HF Long-term follow-up

Summary

The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up. Investigators are free to choose whatever available treatment they believe is in the patient's best interest.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.
medtronic crt insync® family devices Resynchronisation system of the InSync® family
Implantation of CRT device and medical treatment according normal hospital routine.

Primary Outcomes

Measure
All cause Mortality
time frame: 4-year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients who have participated in the CARE-HF program and were reported to be alive in May 2005 - Patients who signed a patient data release consent form Exclusion Criteria: - Patients who have not participated in the CARE-HF program - Patients with exclusion criteria required by local legislation

Additional Information

Official title CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-Term Follow-up
Description The CARE-HF study enrolled 813 patients from 82 centers in 12 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK). All patients that were reported to be alive in May 2005 will be asked to participate.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Medtronic Bakken Research Center.