Clinical Benefits in Optimized Remote HF Patient Management

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.

Conditions

• Congestive Heart Failure Treated

Interventions

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

Sponsors & Collaborators

• Abbott Medical Devices

  lead INDUSTRY

Principal Investigators

• Luigi Padeletti, Prof. · Azienda Ospedaliero-Universitaria Careggi

• Maria Grazia Bongiorni, MD · Ospedale S.Chiara-Cisanello, Pisa

• Gerardo Ansalone, MD · Ospedale Vannini, Roma

• Gianluca Botto, MD · Ospedale S. Anna, Como

• Antonio Curnis, MD · Spedali Civili, Brescia

• Stefano Favale, Prof. · Policlinico Consorziale, Bari

• Edoardo Gronda, MD · Multimedica IRCCS, Milano

• Roberto Verlato, MD · Ospedale Pietro Cosma, Camposampiero (PD)

• Alessandro Proclemer, MD · Ospedale S.M. della Misericordia, Udine

• Luca Santini, MD · University of Rome Tor Vergata

• Alessandro Capucci, Prof. · Azienda Ospedaliero, Universitaria Ospedali Riuniti

• Francesco Solimene, MD · Casa di Cura "Montevergine", Mercogliano (AV)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2016-08-31

Completion

2016-09-30

Countries

• Italy

Study Locations