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CareLink® Network Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01023022
First received: November 26, 2009
Last updated: April 21, 2015
Last verified: April 2015
  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 ]
    "Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"


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 ]
    "Participants were asked questions to which they could have respond multiple answers. 1) Which form of device follow up do you prefer? Answers: Monitor from home and in hospital follow up is necessary; Follow up only in hospital; No preference, and 2) How would you judge the user friendliness of the monitor in total? Answers: Very easy; Easy; Difficult; Missing Data, and 3) How did the monitor changed your daily life? did you felt more or less safe? Answers: Much more safe; Safe; No influence; Unsafe; Missing data

  • 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 ]
    "Investigators were asked to classify reasons for unscheduled visits by marking all applicable answers. Answer: 1) patient symptoms 2) adequate therapy/shock 3) appearance of already known arrythmias 4) appearance of new arrythmias 5) need for reprogramming 6) in house Follow-up 7) device alert 8) inadequate therapy/shock 9) worsening of pump function 10) malfunction of the device 11) other"


Enrollment: 176
Study Start Date: January 2010
Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Medtronic CareLink® Network

Patients with implanted Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.

The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.

Other: Medtronic CareLink® Network
The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website

Detailed Description:

Evaluation's objectives:

Comparison of remote device check and in-clinic device assessment. To assess patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor To assess clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website To assess the clinic specific clinical value of Medtronic CareLink® Network Demonstrate time savings for patients Demonstrate time savings for physicians To show the increase of efficiency through increased flexibility and per procedure time To demonstrate better handling of unscheduled activities (symptoms, events, etc.)

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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 Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) device that is supported by the Medtronic CareLink® Network.
Criteria

Inclusion Criteria:

  • Patients who have an implanted Medtronic ICD, CRT-D 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
John Paul II Hospital, Clinic of Electrocardiology
Cracow, Poland
The University Hospital in Krakow; I Department of Cardiology
Cracow, Poland
I Cardiology Clinic, Clinical University Center
Gdansk, Poland
I Department of Cardiology, Medical University in Poznan
Poznan, Poland
Cardiology Clinic, Pomeranian Medical University SPSK-2
Szczecin, Poland
Public Independent Central Clinical Hospital - SP-CSK
Warsaw, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease
Warsaw, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department
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
Principal Investigator: Hanna Szwed, Prof. Institute of Cardiology, Warsaw, Poland, Spartanska 1
  More Information

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
Results First Received: August 22, 2014
Last Updated: April 21, 2015
Health Authority: Poland: 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 September 29, 2016