Full Automaticity and Remote Follow-up

NCT01526629 | Completed Results

• 1 other identifier: 1047
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachyarrhythmia

Keywords

ICD; Remote follow-up

Outcome Measures

Primary Outcomes (1)

• Remote Follow-up as an Alternative to Onsite Visit

  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

  13 months

Study Arms (1)

ICD patients with remote follow-up

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (1)

CH Montfermeil

Montfermeil, 93370, France

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Latifa Foudali
• Organization: Medtronic

latifa.foudali@medtronic.com

0155381700

Study Officials

• Walid Amara, MD

  Centre Hospitalier de Montfermeil

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: February 6, 2012
• Study Start: May 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 2, 2025
• Results First Posted: June 29, 2017

Record last verified: 2017-02

Locations

FR (1)