NCT01482598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

October 1, 2020

Enrollment Period

4.8 years

First QC Date

November 28, 2011

Results QC Date

March 31, 2020

Last Update Submit

October 22, 2020

Conditions

Congestive Heart Failure Treated

Keywords

Heart FailureCardiac Resynchronization TherapyRemote CareDisease Management

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Optimal Remote Care

ACTIVE COMPARATOR

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

Optimal Standard Care

NO INTERVENTION

Patient standard in clinic visits are performed every 6 months.

Interventions

Remote Care Follow upDEVICE

Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed

Also known as: Home monitoring, Remote monitoring, Merlin.net
Optimal Remote Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Casa di Cura "Montevergine"

Mercogliano, Avellino, Italy

Location

Ospedale Pietro Cosma

Camposampiero, Padova, Italy

Location

Osp. S.Raffaele Giglio

Cefalù, Palermo, Italy

Location

Presidio Ospedaliero Riunito di Ciriè

Cirié, Torino, Italy

Location

Presidio Ospedaliero di Conegliano

Conegliano, Treviso, Italy

Location

Casa di Cura Pederzoli

Peschiera del Garda, Verona, Italy

Location

Azienda Ospedaliero Universitaria "Ospedali Riuniti"

Ancona, Italy

Location

Policlinico Consorziale

Bari, Italy

Location

Spedali Civili

Brescia, Italy

Location

Ospedale Ferrarotto Vittorio Emanuele

Catania, Italy

Location

Ospedale S. Anna

Como, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Location

Azienda Ospedaliera dei Colli - Ospedale Monaldi

Napoli, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Ospedale S. Chiara - Cisanello

Pisa, Italy

Location

Ospedale Vannini

Roma, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Ospedale di Belcolle

Viterbo, Italy

Location

Related Publications (5)

  • Santini M, Ricci RP, Lunati M, Landolina M, Perego GB, Marzegalli M, Schirru M, Belvito C, Brambilla R, Guenzati G, Gilardi S, Valsecchi S. Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes. J Interv Card Electrophysiol. 2009 Jan;24(1):53-61. doi: 10.1007/s10840-008-9321-3. Epub 2008 Oct 31.

    PMID: 18975066BACKGROUND

  • Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x.

    PMID: 18811805BACKGROUND

  • Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, McRae S, Toledo GB, Sarkar S, Hettrick DA; FAST Study Investigators. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). Congest Heart Fail. 2011 Mar-Apr;17(2):51-5. doi: 10.1111/j.1751-7133.2011.00220.x. Epub 2011 Mar 21.

    PMID: 21449992BACKGROUND

  • Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034.

    PMID: 20569704BACKGROUND

  • Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.

    PMID: 21080835BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Alessandra Denaro, Sr. Director Clinical Site Management
Organization
Abbott
alessandra.denaro@abbott.com

Study Officials

  • Luigi Padeletti, Prof.

    Azienda Ospedaliero-Universitaria Careggi

    STUDY CHAIR

  • Maria Grazia Bongiorni, MD

    Ospedale S.Chiara-Cisanello, Pisa

    PRINCIPAL INVESTIGATOR

  • Gerardo Ansalone, MD

    Ospedale Vannini, Roma

    PRINCIPAL INVESTIGATOR

  • Gianluca Botto, MD

    Ospedale S. Anna, Como

    PRINCIPAL INVESTIGATOR

  • Antonio Curnis, MD

    Spedali Civili, Brescia

    PRINCIPAL INVESTIGATOR

  • Stefano Favale, Prof.

    Policlinico Consorziale, Bari

    PRINCIPAL INVESTIGATOR

  • Edoardo Gronda, MD

    Multimedica IRCCS, Milano

    PRINCIPAL INVESTIGATOR

  • Roberto Verlato, MD

    Ospedale Pietro Cosma, Camposampiero (PD)

    PRINCIPAL INVESTIGATOR

  • Alessandro Proclemer, MD

    Ospedale S.M. della Misericordia, Udine

    PRINCIPAL INVESTIGATOR

  • Luca Santini, MD

    University of Rome Tor Vergata

    PRINCIPAL INVESTIGATOR

  • Alessandro Capucci, Prof.

    Azienda Ospedaliero, Universitaria Ospedali Riuniti

    PRINCIPAL INVESTIGATOR

  • Francesco Solimene, MD

    Casa di Cura "Montevergine", Mercogliano (AV)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

November 30, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

November 16, 2020

Results First Posted

November 16, 2020

Record last verified: 2020-10

Locations

IT(18)