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The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic CareLink® Network | Other | The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Baseline to max. 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Szwed, Prof. | Institute of Cardiology, Warsaw, Poland, Spartanska 1 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Paul II Hospital, Clinic of Electrocardiology | Cracow | Poland | ||||
| The University Hospital in Krakow; I Department of Cardiology |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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" | Number of Investigators who provided responded for these questions at the end of evaluation. | Posted | Number | percentage of Investigators | Baseline to max. 12 months |
|
1 year
Only information regarding death were collected during study; none other serious and non-serious adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Implanted ICD or CRT-D Devices | Patients with implanted ICD or CRT-D devices, who will be monitored via CareLink Network System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | exacerbation of cardiac insufficiency |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Hanna Szwed | Institute of Cardiology | 48 22 343 46 00 | hszwed@ikard.pl |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| 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 |
| 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) | "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" | Baseline to max. 12 months |
| Cracow |
| Poland |
| I Cardiology Clinic, Clinical University Center | Gdansk | Poland |
| I Department of Cardiology, Medical University in Poznan | Poznan | Poland |
| Cardiology Clinic, Pomeranian Medical University SPSK-2 | Szczecin | Poland |
| Public Independent Central Clinical Hospital - SP-CSK | Warsaw | Poland |
| The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease | Warsaw | Poland |
| The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department | Warsaw | Poland |
| 4th Military Clinical Hospital, Clinic of Cardiology | Wroclaw | Poland |
| Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy | Zabrze | Poland |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
|
|
| Secondary | 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 | Number of patients who provided responses for these questions at the end of the Study. | Posted | Number | percentage of patients | Baseline to max. 12 months |
|
|
|
| Secondary | 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) | Not Posted | Baseline to max. 12 months | Participants |
| Secondary | Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility) | Not Posted | Baseline to max. 12 months | Participants |
| Secondary | Time and Cost Savings for Patients | Not Posted | Baseline to max. 12 months | Participants |
| Secondary | Time and Costs Savings for Physicians | Not Posted | Baseline to max. 12 months | Participants |
| Secondary | Efficiency Through Increased Flexibility and Per Procedure Time | Not Posted | Baseline to max. 12 months | Participants |
| Secondary | 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" | The 68 patients of total population (176) were analyzed as this number of pt. had experienced unscheduled visit during the study. | Posted | Number | % of unscheduled visits due to reasons | Baseline to max. 12 months | unscheduled visits | unscheduled visits |
|
|
|
| 5 |
| 176 |
| 0 |
| 0 |
| Death | Gastrointestinal disorders | Systematic Assessment | peritonitis due to malignant sigmoid tumour |
|
| Death | General disorders | Systematic Assessment | cause not determined |
|
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| Title | Measurements |
|---|---|
|
| Question 1: Missing data |
|
| Question 2: Very easy |
|
| Question 2: Easy |
|
| Question 2: Difficult |
|
| Question 2: Missing data |
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| Question 3: Much more safer |
|
| Question 3: Safe |
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| Question 3: No influence |
|
| Question 3: Unsafe |
|
| Question 3: Missing data |
|
| Title | Measurements |
|---|---|
|
| Reason 4:appearance of new arrythmias |
|
| Reason 5: need of reprograming |
|
| Reason 6: in house Fup after Carelink control |
|
| Reason 7: device alert |
|
| Reason 8: inadequate therapy/shock |
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| Reason 9: worsening of pump function |
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| Reason 10: malfunction of the device |
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| Reason 11: Other |
|