CareLink® Evaluation
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Bakken Research Center
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
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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
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 May 22, 2013