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Full Automaticity and Remote Follow-up

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01526629
First Posted: February 6, 2012
Last Update Posted: June 29, 2017
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.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  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

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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


Enrollment: 354
Study Start Date: May 2011
Study Completion Date: March 2015
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

Information from the National Library of Medicine

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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
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01526629     History of Changes
Other Study ID Numbers: 1047
First Submitted: November 14, 2011
First Posted: February 6, 2012
Results First Submitted: February 14, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: February 2017

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

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