Clinical trial NCT01023022: CareLink® Network Evaluation
Official title: Medtronic CareLink® Network Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: CareLink
Remote Monitoring
Cardiac Pacemaker, Artificial
Implantable Cardioverter-Defibrillators
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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)

Primary outcomes:
measure: Comparison of Remote Device Check and In-clinic Device Assessment
timeFrame: Baseline to max. 12 months
Secondary outcomes:
measure: 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)
timeFrame: Baseline to max. 12 months
measure: 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)
timeFrame: Baseline to max. 12 months
measure: Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)
timeFrame: Baseline to max. 12 months
measure: Time and Cost Savings for Patients
timeFrame: Baseline to max. 12 months
measure: Time and Costs Savings for Physicians
timeFrame: Baseline to max. 12 months
measure: Efficiency Through Increased Flexibility and Per Procedure Time
timeFrame: Baseline to max. 12 months
measure: Handling of Unscheduled Activities (for Example, Symptoms and Events)
timeFrame: Baseline to max. 12 months
Other outcomes:
Locations:
city: Cracow
country: Poland
facility: John Paul II Hospital, Clinic of Electrocardiology
city: Cracow
country: Poland
facility: The University Hospital in Krakow; I Department of Cardiology
city: Gdansk
country: Poland
facility: I Cardiology Clinic, Clinical University Center
city: Poznan
country: Poland
facility: I Department of Cardiology, Medical University in Poznan
city: Szczecin
country: Poland
facility: Cardiology Clinic, Pomeranian Medical University SPSK-2
city: Warsaw
country: Poland
facility: Public Independent Central Clinical Hospital - SP-CSK
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department
city: Wroclaw
country: Poland
facility: 4th Military Clinical Hospital, Clinic of Cardiology
city: Zabrze
country: Poland
facility: Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy
Study officials:
affiliation: Institute of Cardiology, Warsaw, Poland, Spartanska 1
name: Hanna Szwed, Prof.
role: PRINCIPAL_INVESTIGATOR
References: