CareLink® Network Evaluation
- Conditions
- Heart Failure
- Interventions
- Other: Medtronic CareLink® Network
- Registration Number
- NCT01023022
- Lead Sponsor
- Medtronic Bakken Research Center
- 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.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- 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
- Patients with exclusion criteria required by local law
- Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Medtronic CareLink® Network 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.
- Primary Outcome Measures
Name Time Method Comparison of Remote Device Check and In-clinic Device Assessment Baseline to max. 12 months "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
Name Time Method 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 "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
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 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 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) Baseline to max. 12 months "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"
Trial Locations
- Locations (10)
Public Independent Central Clinical Hospital - SP-CSK
🇵🇱Warsaw, Poland
Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy
🇵🇱Zabrze, Poland
The University Hospital in Krakow; I Department of Cardiology
🇵🇱Cracow, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease
🇵🇱Warsaw, Poland
John Paul II Hospital, Clinic of Electrocardiology
🇵🇱Cracow, Poland
I Department of Cardiology, Medical University in Poznan
🇵🇱Poznan, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department
🇵🇱Warsaw, Poland
4th Military Clinical Hospital, Clinic of Cardiology
🇵🇱Wroclaw, Poland
I Cardiology Clinic, Clinical University Center
🇵🇱Gdansk, Poland
Cardiology Clinic, Pomeranian Medical University SPSK-2
🇵🇱Szczecin, Poland