Trial Outcomes & Findings for CareLink® Network Evaluation (NCT NCT01023022)
NCT ID: NCT01023022
Last Updated: 2025-07-02
Results Overview
"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"
Recruitment status
COMPLETED
Target enrollment
176 participants
Primary outcome timeframe
Baseline to max. 12 months
Results posted on
2025-07-02
Participant Flow
Participant milestones
| Measure |
Medtronic CareLink® Network
Patients with 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.
Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website
|
|---|---|
|
Overall Study
STARTED
|
176
|
|
Overall Study
COMPLETED
|
162
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Medtronic CareLink® Network
Patients with 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.
Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
due to technical issues
|
2
|
Baseline Characteristics
CareLink® Network Evaluation
Baseline characteristics by cohort
| Measure |
Medtronic CareLink® Network
n=176 Participants
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
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
176 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to max. 12 monthsPopulation: Number of Investigators who provided responded for these questions at the end of evaluation.
"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"
Outcome measures
| Measure |
Medtronic CareLink® Network
n=10 Participants
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
|
|---|---|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 7:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 1: Significantly exceeded
|
40.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 1: Goals met
|
50.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 1: No expectations
|
10.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 1:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 1:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 2: Significantly exceeded
|
20 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 2: Goals met
|
80 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 2: No expectations
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 2:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 2:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 3: Significantly exceeded
|
10.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 3: Goals met
|
70.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 3: No expectations
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 3:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 3:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 4: Significantly exceeded
|
10.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 4: Goals met
|
70.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 4: No expectations
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 4:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 4:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 5: Significantly exceeded
|
30.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 5: Goals met
|
70.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 5: No expectations
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 5:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 5:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 6: Significantly exceeded
|
10.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 6: Goals met
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 6: No expectations
|
70.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 6:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 6:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 7: Significantly exceeded
|
10.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 7: Goals met
|
60.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 7: No expectations
|
30.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 7:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 8: Significantly exceeded
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 8: Goals met
|
60.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 8: No expectations
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 8:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 8:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 9: Significantly exceeded
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 9: Goals met
|
60.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 9: No expectations
|
20 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 9:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 9:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 10: Significantly exceeded
|
10.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 10: Goals met
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 10: No expectations
|
50.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 10:Not met
|
20.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 10:Not met at all
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Qestion 11: Significantly exceeded
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 11: Goals met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 11: No expectations
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 11:Not met
|
0.0 percentage of Investigators
|
|
Comparison of Remote Device Check and In-clinic Device Assessment
Answer for Question 11:Not met at all
|
0.0 percentage of Investigators
|
SECONDARY outcome
Timeframe: Baseline to max. 12 monthsPopulation: Number of patients who provided responses for these questions at the end of the Study.
"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
Outcome measures
| Measure |
Medtronic CareLink® Network
n=149 Participants
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
|
|---|---|
|
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)
Question 1: Monitor f. home & in hospital f-up is
|
71.8 percentage of patients
|
|
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)
Question 1: Follow up only in hospital
|
8.7 percentage of patients
|
|
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)
Question 1: No preference
|
18.8 percentage of patients
|
|
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)
Question 1: Missing data
|
0.7 percentage of patients
|
|
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)
Question 2: Very easy
|
65.1 percentage of patients
|
|
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)
Question 2: Easy
|
32.9 percentage of patients
|
|
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)
Question 2: Difficult
|
1.3 percentage of patients
|
|
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)
Question 2: Missing data
|
0.7 percentage of patients
|
|
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)
Question 3: Much more safer
|
44.3 percentage of patients
|
|
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)
Question 3: Safe
|
50.3 percentage of patients
|
|
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)
Question 3: No influence
|
4.7 percentage of patients
|
|
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)
Question 3: Unsafe
|
0 percentage of patients
|
|
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)
Question 3: Missing data
|
0.7 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to max. 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to max. 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to max. 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to max. 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to max. 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to max. 12 monthsPopulation: The 68 patients of total population (176) were analyzed as this number of pt. had experienced unscheduled visit during the study.
"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"
Outcome measures
| Measure |
Medtronic CareLink® Network
n=116 unscheduled visits
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
|
|---|---|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 1: patient symptoms
|
25.9 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 2: adequate therapy/shock
|
14.7 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 3: appearance of already known arrythmias
|
0.9 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 4:appearance of new arrythmias
|
2.6 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 5: need of reprograming
|
1.7 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 6: in house Fup after Carelink control
|
4.3 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 7: device alert
|
17.2 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 8: inadequate therapy/shock
|
6.0 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 9: worsening of pump function
|
0.9 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 10: malfunction of the device
|
0.0 % of unscheduled visits due to reasons
|
|
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Reason 11: Other
|
44.8 % of unscheduled visits due to reasons
|
Adverse Events
Patients With Implanted ICD or CRT-D Devices
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Implanted ICD or CRT-D Devices
n=176 participants at risk
Patients with implanted ICD or CRT-D devices, who will be monitored via CareLink Network System
|
|---|---|
|
Cardiac disorders
Death
|
1.7%
3/176 • Number of events 3 • 1 year
Only information regarding death were collected during study; none other serious and non-serious adverse events were collected.
|
|
Gastrointestinal disorders
Death
|
0.57%
1/176 • Number of events 1 • 1 year
Only information regarding death were collected during study; none other serious and non-serious adverse events were collected.
|
|
General disorders
Death
|
0.57%
1/176 • Number of events 1 • 1 year
Only information regarding death were collected during study; none other serious and non-serious adverse events were collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60