Full Automaticity and Remote Follow-up

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01526629
First received: November 14, 2011
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years. This has resulted in an increase of the number of follow-up (FU) to be performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events.

The objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote FU can be an alternative to onsite visit.


Condition
Tachyarrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Profile of patient with remote follow-up requiring a site visit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Identification of the profile of patients implanted with a fully automatic ICD and remotely followed-up that requires a site visit


Secondary Outcome Measures:
  • Remote follow-up as an alternative to onsite visit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluate in which proportion remote follow-up may represent an alternative to onsite visit for patients implanted with a fully automatic ICD

  • Capacity to predict the need for onsite FU based on the analysis of remote follow-up data [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Evaluate the sensibility and specificity of remote follow-up data to predict the need of an onsite visit

    Sensibility is defined as follows:

    Number of cases where remote FU data analysis has shown reliably the need of an onsite visit divided by the total number of cases where an onsite was needed as defined per protocol.

    Specificity is defined as follows:

    Number of cases where remote FU data analysis has shown reliably that there was no need for an onsite visit divided by the total number of cases where there was no need for an onsite visit.


  • Type of reprogramming during onsite visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Describe the type of reprogramming performed during onsite visits

  • Patient constraints associated with an onsite visit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Describe patient constraints associated with an onsite visit


Estimated Enrollment: 385
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICD patients with remote follow-up
Patients implanted with a fully automatic ICD and remotely followed-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient implanted with a sigle- or dual-chamber ICD or a Cardiac Resynchronization-Defibrillator system (CRT-D) and remotely followed-up

Criteria

Inclusion Criteria:

  • Patient older than 18,
  • Patient implanted with a fully automatic ICD and remotely followed-up,
  • Patient geographically stable and able to attend FU at investigative site
  • Patient who signed a data release authorization form,

Exclusion Criteria:

  • Patient whose mental or physical capacity impedes to give an informed data release authorization,
  • Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
  • Patients in New York Heart Association (NYHA) class IV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526629

Locations
France
CH Montfermeil
Montfermeil, France, 93370
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Walid Amara, MD Centre Hospitalier de Montfermeil
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01526629     History of Changes
Other Study ID Numbers: 1047
Study First Received: November 14, 2011
Last Updated: December 18, 2013
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: The Commission nationale de l’informatique et des libertés
France: Conseil National de l'Ordre des Médecins

Keywords provided by Medtronic Bakken Research Center:
ICD
Remote follow-up

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014