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CareLink® Evaluation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01023022
First received: November 26, 2009
Last updated: April 25, 2012
Last verified: April 2012
History of Changes

November 26, 2009
April 25, 2012
January 2010
October 2012   (final data collection date for primary outcome measure)
Comparison of remote device check and in-clinic device assessment [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
Comparison of remote device check and in-clinic device assessment [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01023022 on ClinicalTrials.gov Archive Site
  • Patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor (including percentage of patients who prefer follow up with Medtronic CareLink® compared to traditional in-clinic device follow-up) [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
  • Clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website (including clinician general preference, if any, for Medtronic CareLink® compared to traditional in-clinic device follow-up) [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
  • Clinic-specific clinical value of Medtronic CareLink® Network (change of workflow, increase of flexibility) [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
  • Time and cost savings for patients [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
  • Time and costs savings for physicians [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
  • Efficiency through increased flexibility and per procedure time [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
  • Handling of unscheduled activities (for example, symptoms and events) [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]
  • Patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor (including percentage of patients who prefer follow up with Medtronic CareLink® compared to traditional in-clinic device follow-up) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website (including clinician general preference, if any, for Medtronic CareLink® compared to traditional in-clinic device follow-up) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Clinic-specific clinical value of Medtronic CareLink® Network (change of workflow, increase of flexibility) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Time and cost savings for patients [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Time and costs savings for physicians [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Efficiency through increased flexibility and per procedure time [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Handling of unscheduled activities (for example, symptoms and events) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CareLink® Evaluation
Medtronic CareLink® Network Evaluation Protocol

The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients under the care at a participating study location who have an implanted Medtronic Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy-Pacemaker(CRT-P), Cardiac Resynchronization Therapy-Defibrillator (CRT-D) or Implantable Loop Recorder (ILR) device that is supported by the Medtronic CareLink® Network.
Heart Failure
Other: Medtronic CareLink® Network
The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website
  • Patients followed per standard of care
  • Patients followed using Medtronic CareLink®
    Intervention: Other: Medtronic CareLink® Network
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
520
Not Provided
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have an implanted Medtronic IPG, ICD, CRT-P, CRT-D or ILR device that is supported by the Medtronic CareLink® Network
  • Patients have to sign the Medtronic CareLink® "Statement of Privacy Principles" and the "Evaluation Data Protection Statement" documents

Exclusion Criteria:

  • Patients with exclusion criteria required by local law
  • Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01023022
MDT-CareLinkEval
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Study Chair: Zsolt Torok, MD Medtronic
Medtronic Bakken Research Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP