Overview

This trial is active, not recruiting.

Condition tachyarrhythmia
Sponsor Medtronic Bakken Research Center
Collaborator Medtronic
Start date May 2011
End date March 2015
Trial size 385 participants
Trial identifier NCT01526629, 1047

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients implanted with a fully automatic ICD and remotely followed-up.

Primary Outcomes

Measure
Profile of patient with remote follow-up requiring a site visit
time frame: 1 year

Secondary Outcomes

Measure
Remote follow-up as an alternative to onsite visit
time frame: 1 year
Capacity to predict the need for onsite FU based on the analysis of remote follow-up data
time frame: 1 year
Type of reprogramming during onsite visits
time frame: 1 year
Patient constraints associated with an onsite visit
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit
Principal investigator Walid Amara, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Medtronic Bakken Research Center.