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The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™.
The primary goal is to learn how many CareLink quarterly scheduled transmissions are completed within a prescribed time period to assess CareLink scheduled transmission compliance. The evaluation will also assess adoption to remote monitoring, patient perceived benefit of BlueSync™ (how patients interact with the smart device application) and health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™ (benefits experienced by clinicians that use BlueSync™).
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CRF 11.24 and 11.44).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation Group | Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App |
| |
| Control Group | Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation Group | Other | Patient receiving exposure to the MyCareLink Heart App during device pairing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic CareLink Transmission Success | To assess CareLink transmission compliance (adherence to scheduled transmission), the primary objective is to compare the percentages of the CareLink quarterly scheduled transmissions that are completed within the prescribed window during the 12-month follow-up after the baseline visit in the CareLink Database between the evaluation patients who use the MyCareLink Heart™ (MCL) app and patients with low power devices and CareLink monitors 2490 (excluding wireless model 2490C). For both patient groups, all scheduled transmissions between 1 and 12 months after enrollment/CareLink activation were included. The results reflect the total percentage of completed transmissions pooled across subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis. A 95% confidence interval based on generalized estimating equations for binomial distribution was calculated for the percentage of completed scheduled transmissions. | Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation |
| Measure | Description | Time Frame |
|---|---|---|
| Acute CareLink Transmission Success | To assess acute CareLink transmission compliance (adherence to scheduled transmission), the secondary objective is to characterize the percentage of the CareLink bi-weekly scheduled transmissions that are completed within the prescribed window during the 1-month follow-up after the baseline visit in the CareLink Database via the MCL Heart™ app. All scheduled transmissions within the first month after enrollment were included in the analysis. The results reflect the total percentage of completed transmissions pooled across all subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis since there were several transmissions per subject. A two-sided 95% confidence interval based on generalized estimating equations (GEE) for binomial distribution was calculated for the percentage of completed scheduled transmissions. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at hospitals and clinics specializing in the implant and followup of pacemakers and CRT-P devices using remote monitoring
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| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Trajki, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Universithy | Palo Alto | California | 94305 | United States | ||
| Hartford Hosital |
There are not plans to share IPD with other researchers
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Historical Controls were not considered enrolled in this study. The patients' data was extracted from Medtronic de-identified CareLink™ database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evaluation Group | Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App Evaluation Group: Patient receiving exposure to the MyCareLink Heart App during device pairing |
| FG001 | Control Group (Historical) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Version 1 | Apr 4, 2017 | Jan 29, 2021 |
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| Control Group (Historical) | Other | Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C). The patients' data will be extracted from Medtronic de-identified CareLink™ database. |
|
| Scheduled transmissions in the first month after enrollment |
| Hartford |
| Connecticut |
| 06102 |
| United States |
| Daytona Heart Group | Daytona Beach | Florida | 32114 | United States |
| Cardiovascular Institutes of Orland0 | Orlando | Florida | 32822 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| CentraCare | Saint Cloud | Minnesota | 56303 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Cone Health | Greensboro | North Carolina | 27401 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Mount Carmel | Columbus | Ohio | 43213 | United States |
| East Tennessee Consultants | Knoxville | Tennessee | 37934 | United States |
| CHU Bordeaux | Bordeaux | France |
| CHI Toulouse | Toulouse | France |
| Istituto clinico Città Studi | Milan | Italy |
| Ospedale Sacro Cuore | Negrar | 37024 | Italy |
| Provincia Religiosa San Pietro Di Roma | Rome | Italy |
| Sandwell and West Birmingham Hospitals | Birmingham | B71 4HJ | United Kingdom |
| Manchester Royal Infirmary | Manchester | M139WC | United Kingdom |
| Southampton | Southampton | SO166YD | United Kingdom |
| University Hospital of North Midlands NHS Trust | Stoke-on-Trent | United Kingdom |
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C) |
| COMPLETED |
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| NOT COMPLETED |
|
|
Patients enrolled in the BlueSync Field Evaluation
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| ID | Title | Description |
|---|---|---|
| BG000 | Evaluation Group | Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App |
| BG001 | Control Group (Historical) | Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | For the control group, the gender information was not available for all subjects in the CareLink database. Gender was unknown for 351 subjects in the control group. | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
|
| 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 | Chronic CareLink Transmission Success | To assess CareLink transmission compliance (adherence to scheduled transmission), the primary objective is to compare the percentages of the CareLink quarterly scheduled transmissions that are completed within the prescribed window during the 12-month follow-up after the baseline visit in the CareLink Database between the evaluation patients who use the MyCareLink Heart™ (MCL) app and patients with low power devices and CareLink monitors 2490 (excluding wireless model 2490C). For both patient groups, all scheduled transmissions between 1 and 12 months after enrollment/CareLink activation were included. The results reflect the total percentage of completed transmissions pooled across subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis. A 95% confidence interval based on generalized estimating equations for binomial distribution was calculated for the percentage of completed scheduled transmissions. | Posted | Number | 95% Confidence Interval | Percentage of completed transmissions | Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation |
|
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| Secondary | Acute CareLink Transmission Success | To assess acute CareLink transmission compliance (adherence to scheduled transmission), the secondary objective is to characterize the percentage of the CareLink bi-weekly scheduled transmissions that are completed within the prescribed window during the 1-month follow-up after the baseline visit in the CareLink Database via the MCL Heart™ app. All scheduled transmissions within the first month after enrollment were included in the analysis. The results reflect the total percentage of completed transmissions pooled across all subjects taking into account that there were several transmissions per subject. A correlated data method was required for the analysis since there were several transmissions per subject. A two-sided 95% confidence interval based on generalized estimating equations (GEE) for binomial distribution was calculated for the percentage of completed scheduled transmissions. | In total, 215 patients had at least one scheduled transmission within the first month, and were available for analysis. Of the 257 enrolled patients, one patient was not available in CareLink, four patients left the evaluation early which resulted in data loss within CareLink, 37 patients had no scheduled transmission in the first month. | Posted | Number | 95% Confidence Interval | Percentage of completed transmissions | Scheduled transmissions in the first month after enrollment |
|
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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 | Evaluation Group | Adverse events were not collected in the evaluation. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Control Group (Historical) | Adverse events are not available from the control group since the data of these patients is extracted from the Medtronic de-identified CareLink™ database. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Holloman | CRHF Clinical | 763-526-1545 | keith.holloman@medtronic.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Version 2 | Jul 18, 2017 | Jan 29, 2021 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Version 3 | Jul 19, 2017 | Jan 29, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2019 | Mar 5, 2021 | SAP_003.pdf |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D055991 | Health Records, Personal |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
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| Between 18 and 65 years |
|
| >=65 years |
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| Italy |
|
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| United Kingdom |
|
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| France |
|
|
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| High School |
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| Bachelor |
|
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| Master |
|
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| PhD/Doctorate |
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| <0.001 |
The threshold for statistical significance was 0.025. |
| Mean Difference (Final Values) |
| 38.3 |
| 2-Sided |
| 95 |
| 34.8 |
| 41.9 |
| Superiority |
|
|