CareLink® Network Evaluation

NCT01023022 | Completed Results

• 1 other identifier: MDT-CareLinkEval
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Heart Failure

Keywords

CareLink; Remote Monitoring; Cardiac Pacemaker, Artificial; Implantable Cardioverter-Defibrillators

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

  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

Study Arms (1)

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

Interventions

Medtronic CareLink® Network OTHER

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

Medtronic CareLink® Network

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (10)

I Cardiology Clinic, Clinical University Center

Gdansk, Poland

Location

John Paul II Hospital, Clinic of Electrocardiology

Krakow, Poland

Location

The University Hospital in Krakow; I Department of Cardiology

Krakow, Poland

Location

I Department of Cardiology, Medical University in Poznan

Poznan, Poland

Location

Cardiology Clinic, Pomeranian Medical University SPSK-2

Szczecin, Poland

Location

Public Independent Central Clinical Hospital - SP-CSK

Warsaw, Poland

Location

The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease

Warsaw, Poland

Location

The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department

Warsaw, Poland

Location

4th Military Clinical Hospital, Clinic of Cardiology

Wroclaw, Poland

Location

Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy

Zabrze, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Prof. Hanna Szwed
• Organization: Institute of Cardiology

hszwed@ikard.pl

48 22 343 46 00

Study Officials

• Hanna Szwed, Prof.

  Institute of Cardiology, Warsaw, Poland, Spartanska 1

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 1, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 2, 2025
• Results First Posted: April 23, 2015

Record last verified: 2016-11

Locations

PL (10)