CareLink® Network Evaluation

Medtronic CareLink® Network Evaluation Protocol

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01023022

Enrollment

176

Registered

2009-12-01

Start date

2010-01-31

Completion date

2013-10-31

Last updated

2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

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

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.)

Interventions

OTHERMedtronic CareLink® Network

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—
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
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
Time and Costs Savings for Physicians	Baseline to max. 12 months	—

Countries

Poland

Participant flow

Participants by arm

Arm	Count
Medtronic CareLink® Network Patients with implanted ICD or 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. Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website	176
Total	176

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	5
Overall Study	due to technical issues	2
Overall Study	Lost to Follow-up	7

Baseline characteristics

Characteristic	Medtronic CareLink® Network
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	73 Participants
Age, Categorical Between 18 and 65 years	103 Participants
Age, Continuous	61 years STANDARD_DEVIATION 13
Region of Enrollment Poland	176 participants
Sex: Female, Male Female	29 Participants
Sex: Female, Male Male	147 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	5 / 176

Outcome results

Primary

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