NCT01482598

Clinical Benefits in Optimized Remote HF Patient Management

COR HF - Clinical Benefits in Optimized Remote HF Patient Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Congestive Heart Failure Treated

Interventions

Type	Name	Description
DEVICE	Remote Care Follow up	Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2011-11-30
• Last updated: 2020-11-16
• Results posted: 2020-11-16

Locations

18 sites across 1 country: Italy