Full Automaticity and Remote Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526629
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Brief Summary:

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 or disease

Study Type : Observational
Actual Enrollment : 354 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit
Study Start Date : May 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

ICD patients with remote follow-up
Patients implanted with a fully automatic ICD and remotely followed-up.

Primary Outcome Measures :
  1. Remote Follow-up as an Alternative to Onsite Visit [ Time Frame: 13 months ]
    Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526629

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

Responsible Party: Medtronic Bakken Research Center Identifier: NCT01526629     History of Changes
Other Study ID Numbers: 1047
First Posted: February 6, 2012    Key Record Dates
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: February 2017

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

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