CareLink® Network 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Medtronic CareLink® Network

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.)

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Poland
  • Cracow, Poland
    • John Paul II Hospital, Clinic of Electrocardiology
  • Cracow, Poland
    • The University Hospital in Krakow; I Department of Cardiology
  • Gdansk, Poland
    • I Cardiology Clinic, Clinical University Center
  • Poznan, Poland
    • I Department of Cardiology, Medical University in Poznan
  • Szczecin, Poland
    • Cardiology Clinic, Pomeranian Medical University SPSK-2
  • Warsaw, 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
  • Wroclaw, Poland
    • 4th Military Clinical Hospital, Clinic of Cardiology
  • Zabrze, Poland
    • Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Remote Device Check and In-clinic Device Assessment	"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"	Baseline to max. 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	"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	Baseline to max. 12 months
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)		Baseline to max. 12 months
Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)		Baseline to max. 12 months
Time and Cost Savings for Patients		Baseline to max. 12 months
Time and Costs Savings for Physicians		Baseline to max. 12 months
Efficiency Through Increased Flexibility and Per Procedure Time		Baseline to max. 12 months
Handling of Unscheduled Activities (for Example, Symptoms and Events)	"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"	Baseline to max. 12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Hanna Szwed, Prof., Institute of Cardiology, Warsaw, Poland, Spartanska 1

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 26, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimated): December 1, 2009

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Remote Monitoring; Cardiac Pacemaker, Artificial; Implantable Cardioverter-Defibrillators; CareLink
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: MDT-CareLinkEval