Clinical Benefits in Optimized Remote HF Patient Management

Not Applicable

Completed

• Conditions: Congestive Heart Failure Treated
• Interventions: Device: Remote Care Follow up

• Registration Number: NCT01482598
• Lead Sponsor: Abbott Medical Devices

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

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-30
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Results First Submitted: 2020-03-31
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Results First Posted: 2020-11-16
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal Remote Care	Remote Care Follow up	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.

Primary Outcome Measures

Name	Time	Method
Combined Endpoint on Patient Clinical Outcome	12 months follow up	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

Trial Locations

Locations (18)

Casa di Cura "Montevergine"; 🇮🇹 Mercogliano, Avellino, Italy

Osp. S.Raffaele Giglio; 🇮🇹 Cefalù, Palermo, Italy

Presidio Ospedaliero di Conegliano; 🇮🇹 Conegliano, Treviso, Italy

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

Ospedale S. Chiara - Cisanello; 🇮🇹 Pisa, Italy

Ospedale di Belcolle; 🇮🇹 Viterbo, Italy

Presidio Ospedaliero Riunito di Ciriè; 🇮🇹 Ciriè, Torino, Italy

Ospedale Pietro Cosma; 🇮🇹 Camposampiero, Padova, Italy

Policlinico Consorziale; 🇮🇹 Bari, Italy

Azienda Ospedaliero Universitaria "Ospedali Riuniti"; 🇮🇹 Ancona, Italy

Casa di Cura Pederzoli; 🇮🇹 Peschiera del Garda, Verona, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

Ospedale Ferrarotto Vittorio Emanuele; 🇮🇹 Catania, Italy

Ospedale S. Anna; 🇮🇹 Como, Italy

Ospedale Guglielmo da Saliceto; 🇮🇹 Piacenza, Italy

Azienda Ospedaliera dei Colli - Ospedale Monaldi; 🇮🇹 Napoli, Italy

Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Ospedale Vannini; 🇮🇹 Roma, Italy