Full Automaticity and Remote Follow-up
|ClinicalTrials.gov Identifier: NCT01526629|
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
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|
|Official Title:||Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit|
|Study Start Date :||May 2011|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
ICD patients with remote follow-up
Patients implanted with a fully automatic ICD and remotely followed-up.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526629
|Montfermeil, France, 93370|
|Principal Investigator:||Walid Amara, MD||Centre Hospitalier de Montfermeil|