CareLink® Evaluation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medtronic Bakken Research Center.
Recruitment status was  Active, not recruiting
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
  Purpose

The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.


Condition Intervention
Heart Failure
Other: Medtronic CareLink® Network

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic CareLink® Network Evaluation Protocol

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Comparison of remote device check and in-clinic device assessment [ Time Frame: Baseline to max. 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 520
Study Start Date: January 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients followed per standard of care
Patients followed using Medtronic CareLink® Other: Medtronic CareLink® Network
The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023022

Locations
Poland
I Cardiology Clinic, Clinical University Center
Gdańsk, Poland
The University Hospital in Krakow; I Department of Cardiology
Krakow, Poland
John Paul II Hospital, Clinic of Electrocardiology
Kraków, Poland
I Department of Cardiology, Medical University in Poznan
Poznan, Poland
Cardiology Clinic, Pomeranian Medical University SPSK-2
Szczecin, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department
Warsaw, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease
Warsaw, Poland
Public Independent Central Clinical Hospital - SP-CSK
Warsaw, Poland
4th Military Clinical Hospital, Clinic of Cardiology
Wroclaw, Poland
Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy
Zabrze, Poland
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Study Chair: Zsolt Torok, MD Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01023022     History of Changes
Other Study ID Numbers: MDT-CareLinkEval
Study First Received: November 26, 2009
Last Updated: April 25, 2012
Health Authority: Poland: Ethics Committee
Czech Republic: Ethics Committee
Hungary: Institutional Ethics Committee

Keywords provided by Medtronic Bakken Research Center:
CareLink
Remote Monitoring
Cardiac Pacemaker, Artificial
Implantable Cardioverter-Defibrillators

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014