Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01526629
Other study ID # 1047
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 14, 2011
Last updated December 18, 2013
Start date May 2011
Est. completion date March 2015

Study information

Verified date December 2013
Source Medtronic Bakken Research Center
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life SciencesFrance: The Commission nationale de l’informatique et des libertésFrance: Conseil National de l'Ordre des Médecins
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 385
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France CH Montfermeil Montfermeil

Sponsors (2)

Lead Sponsor Collaborator
Medtronic Bakken Research Center Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Profile of patient with remote follow-up requiring a site visit Identification of the profile of patients implanted with a fully automatic ICD and remotely followed-up that requires a site visit 1 year No
Secondary Remote follow-up as an alternative to onsite visit Evaluate in which proportion remote follow-up may represent an alternative to onsite visit for patients implanted with a fully automatic ICD 1 year No
Secondary Capacity to predict the need for onsite FU based on the analysis of remote follow-up data Evaluate the sensibility and specificity of remote follow-up data to predict the need of an onsite visit
Sensibility is defined as follows:
Number of cases where remote FU data analysis has shown reliably the need of an onsite visit divided by the total number of cases where an onsite was needed as defined per protocol.
Specificity is defined as follows:
Number of cases where remote FU data analysis has shown reliably that there was no need for an onsite visit divided by the total number of cases where there was no need for an onsite visit.
1 year No
Secondary Type of reprogramming during onsite visits Describe the type of reprogramming performed during onsite visits 1 year No
Secondary Patient constraints associated with an onsite visit Describe patient constraints associated with an onsite visit 1 year No
See also
  Status Clinical Trial Phase
Completed NCT02565238 - BIO.MASTER.BioMonitor 2 Study N/A
Completed NCT02849769 - Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Completed NCT04025710 - Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep) N/A
Active, not recruiting NCT05621187 - Post Market Clinical Follow-up Study for the Pamira ICD Lead Family N/A
Not yet recruiting NCT06382207 - Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs N/A
Completed NCT03850327 - BIO|CONCEPT.BIOMONITOR III N/A
Recruiting NCT04905199 - Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Completed NCT03408951 - Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Not yet recruiting NCT06327425 - MCG for Localization of Tachyarrhythmia's Origin N/A
Recruiting NCT04863664 - Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP) N/A
Not yet recruiting NCT05750108 - Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction N/A
Completed NCT02774616 - BIO|MASTER.Ilivia Family / Plexa N/A
Completed NCT00231426 - ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations Phase 4
Completed NCT02181686 - Iperia/Sentus QP Study N/A
Terminated NCT03451227 - Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures N/A
Completed NCT02933619 - ProMRI ICD/CRT-D Post Approval Study
Completed NCT00324662 - Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA) Phase 4
Completed NCT00170274 - APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias N/A
Completed NCT03891329 - Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead N/A
Completed NCT06323499 - Outcome of Induced Atypical Atrial Flutter