CareLink® Network Evaluation

An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Heart Failure
What is being tested?: Medtronic CareLink® Network
How many people: 176 participants
Where: 10 sitesPoland
Study dates: Jan 2010to Oct 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

Patients with exclusion criteria required by local law
Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Poland10 sites

John Paul II Hospital, Clinic of Electrocardiology
Cracow
The University Hospital in Krakow; I Department of Cardiology
Cracow
I Cardiology Clinic, Clinical University Center
Gdansk
I Department of Cardiology, Medical University in Poznan
Poznan
Cardiology Clinic, Pomeranian Medical University SPSK-2
Szczecin
Public Independent Central Clinical Hospital - SP-CSK
Warsaw
The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease
Warsaw
The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department
Warsaw
4th Military Clinical Hospital, Clinic of Cardiology
Wroclaw
Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy
Zabrze

Other trials in Poland

About this study

Official title: Medtronic CareLink® Network Evaluation Protocol

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

Read the 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.)

Conditions: Heart Failure
Being tested: Medtronic CareLink® Network
Keywords: CareLink, Remote Monitoring, Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillators
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01023022
Study group	Role	What they receive
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. Receives: Other: Medtronic CareLink® Network

What is being measured

The primary outcome is the main question the study is designed to answer.

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"
Measured: 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)
"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
Measured: 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)
Measured: Baseline to max. 12 months
Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)
Measured: Baseline to max. 12 months
Time and Cost Savings for Patients
Measured: Baseline to max. 12 months
Time and Costs Savings for Physicians
Measured: Baseline to max. 12 months
Efficiency Through Increased Flexibility and Per Procedure Time
Measured: Baseline to max. 12 months
Handling of Unscheduled Activities (for Example, Symptoms and Events)
"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"
Measured: Baseline to max. 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Oct 2013

First posted1 Dec 2009 (estimated)
Study startJan 2010
Primary completionMar 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01023022
Sponsor's protocol ID: MDT-CareLinkEval
Status last verified: Nov 2016
First submitted: 26 Nov 2009
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medtronic CareLink® Network Evaluation Protocol
ClinicalTrials.gov ID: NCT01023022
Acronym / sponsor ID: MDT-CareLinkEval
Conditions: Heart Failure
Keywords: CareLink, Remote Monitoring, Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillators
Study type: Observational
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Mar 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 1 Dec 2009 (estimated)
Results: Posted 23 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Medtronic CareLink® Network	–	Other: Medtronic CareLink® NetworkPatients 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

Patients with exclusion criteria required by local law
Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic CareLink® NetworkThe Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website	Other	Medtronic CareLink® Network

Primary outcome

Comparison of Remote Device Check and In-clinic Device Assessment
Time frame: 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"

7 secondary outcomes

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)
Time frame: 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)
Time frame: Baseline to max. 12 months
Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)
Time frame: Baseline to max. 12 months
Time and Cost Savings for Patients
Time frame: Baseline to max. 12 months
Time and Costs Savings for Physicians
Time frame: Baseline to max. 12 months
Efficiency Through Increased Flexibility and Per Procedure Time
Time frame: Baseline to max. 12 months
Handling of Unscheduled Activities (for Example, Symptoms and Events)
Time frame: Baseline to max. 12 months

Results and safety

Results posted to the registry on 23 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medtronic CareLink® Network	176	162

Primary outcome: Comparison of Remote Device Check and In-clinic Device Assessment

Time frame: Baseline to max. 12 months. Number. Unit: percentage of Investigators

Measure	Medtronic CareLink® Network n = 10
Answer for Qestion 1: Significantly exceeded	40.0
Answer for Question 1: Goals met	50.0
Answer for Question 1: No expectations	10.0
Answer for Question 1:Not met	0.0
Answer for Question 1:Not met at all	0.0
Answer for Qestion 2: Significantly exceeded	20
Answer for Question 2: Goals met	80
Answer for Question 2: No expectations	0.0

Population analysed: Number of Investigators who provided responded for these questions at the end of evaluation.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Implanted ICD or CRT-D Devices	5 of 176 (2.8%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heart Failure

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hanna Szwed, Prof. principal investigator

Institute of Cardiology, Warsaw, Poland, Spartanska 1

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Remote Device Check and In-clinic Device Assessment (time frame: Baseline to max. 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01023022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.