Clinical Benefits in Optimized Remote HF Patient Management

Study Overview
=================
Brief 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

Official Title
-----------------
COR HF - Clinical Benefits in Optimized Remote HF Patient Management

Conditions
-----------------
Congestive Heart Failure Treated

Intervention / Treatment
-----------------
* Device: Remote Care Follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Optimal Remote Care<br>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. | Device: Remote Care Follow up<br>* Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed<br>* Other names: Home monitoring, Remote monitoring, Merlin.net;|
| No Intervention: Optimal Standard Care<br>Patient standard in clinic visits are performed every 6 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Endpoint on Patient Clinical Outcome | Combined Endpoint: 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 Cardiac Defibrillator (ICD) therapies delivered at 12 months | 12 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Cardiac Resynchronization Therapy, Remote Care, Disease Management