This trial is active, not recruiting.

Condition congestive heart failure treated
Treatment remote care follow up
Phase phase 4
Sponsor St. Jude Medical
Start date October 2011
End date August 2016
Trial size 438 participants
Trial identifier NCT01482598, CR‐11‐017‐IT‐HF


The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT‐D) device reprogramming.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
Patient follow up is performed through remote care, remote alerts on CRT-D device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.
remote care follow up Home monitoring, Remote monitoring, Merlin.net
Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
(No Intervention)
Patient standard in clinic visits are performed every 6 months.

Primary Outcomes

Combined Endpoint on patient clinical outcome
time frame: 12 months follow up

Secondary Outcomes

Efficacy and safety of CRT in remote care pts
time frame: 12 and 24 months follow up

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Heart failure patients already implanted with CRT‐D devices (from 4 to 8 weeks), according to current guidelines1 - 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months - Left Bundle Branch Block (LBBB) - Patients must be able to provide written informed consent - Patients are mentally capable to participate in the Investigation (based on physician's discretion) Exclusion Criteria: - Patients already implanted with CRT or CRT‐D device to be replaced - Patients in long‐standing persistent or permanent AT/AF - Patients in dialysis treatment at the time of enrollment - Patients in parenteral inotropic therapy at the time of enrollment - Patients with epicardial Left Ventricular (LV) lead - Patients with mechanical valvular prosthesis - Patients with life expectancy < 12 months - Patients actively considered for cardiac transplant - Patients < 18 years old - Pregnant women

Additional Information

Official title COR HF - Clinical Benefits in Optimized Remote HF Patient Management
Principal investigator Maria Grazia Bongiorni, MD
Description The outcome measure of the study is a combined endpoint of: - Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months - Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.