Clinical Benefits in Optimized Remote HF Patient Management (COR-HF)

Abbott

Status: Completed

Conditions: Congestive Heart Failure Treated

Treatments: Device: Remote Care Follow up

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482598

CR-11-017-IT-HF

Details and patient eligibility

About

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.

Full 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

Enrollment: 144 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Optimal Remote Care

Active Comparator group

Description:

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.

Treatment:

Device: Remote Care Follow up

Optimal Standard Care

No Intervention group

Description:

Patient standard in clinic visits are performed every 6 months.