Bradycardia
Conditions
Keywords
remote monitoring, transmission compliance, patient engagement
Brief summary
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™.
Detailed description
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).
Interventions
OTHEREvaluation Group
Patient receiving exposure to the MyCareLink Heart App during device pairing
OTHERControl Group (Historical)
Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C). The patients' data will be extracted from Medtronic de-identified CareLink™ database.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient will be/has been implanted with an Azure™ or Percepta™, Serena™, Solara™ CRT-P device compatible with BlueSync™ (both new and replacement devices are allowed) * Patient must own a smart device (Smartphone or tablet) that meets system requirements and be willing to use during evaluation period * Patient must be able to complete the required 12-month follow-up after enrollment * Patients must be of legal age according to local law
Exclusion criteria
* Patient unwilling to complete required surveys during 12-month evaluation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic CareLink Transmission Success | Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute CareLink Transmission Success | Scheduled transmissions in the first month after enrollment | 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. |
Countries
France, Italy, United Kingdom, United States
Participant flow
Pre-assignment details
Historical Controls were not considered enrolled in this study. The patients' data was extracted from Medtronic de-identified CareLink™ database.
Participants by arm
| Arm | Count |
|---|---|
| Evaluation Group Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App | 257 |
| Control Group (Historical) Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C) | 128,607 |
| Total | 128,864 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 51 | 0 |
Baseline characteristics
| Characteristic | Evaluation Group | Control Group (Historical) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 50 Participants | 50 Participants |
| Age, Categorical >=65 years | 148 Participants | 102072 Participants | 102220 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 26485 Participants | 26594 Participants |
| Age, Continuous | 64.7 years STANDARD_DEVIATION 15.6 | 72.2 years STANDARD_DEVIATION 11.5 | 72.2 years STANDARD_DEVIATION 11.5 |
| Education Bachelor | 86 Participants | NA Participants | NA Participants |
| Education High School | 111 Participants | NA Participants | NA Participants |
| Education Less Than High School | 17 Participants | NA Participants | NA Participants |
| Education Master | 25 Participants | NA Participants | NA Participants |
| Education PhD/Doctorate | 18 Participants | NA Participants | NA Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 8 Participants | 0 Participants | 8 Participants |
| Region of Enrollment Italy | 12 Participants | 0 Participants | 12 Participants |
| Region of Enrollment United Kingdom | 85 Participants | 0 Participants | 85 Participants |
| Region of Enrollment United States | 152 Participants | 128607 Participants | 128759 Participants |
| Sex: Female, Male Female | 109 Participants | 61604 Participants | 61713 Participants |
| Sex: Female, Male Male | 148 Participants | 66652 Participants | 66800 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluation Group | Chronic CareLink Transmission Success | 94.6 Percentage of completed transmissions |
| Control Group (Historical) | Chronic CareLink Transmission Success | 60.0 Percentage of completed transmissions |
| Matched Control Group (Historical) | Chronic CareLink Transmission Success | 56.3 Percentage of completed transmissions |
p-value: <0.00195% CI: [32.4, 37]Generalized estimating equation model
p-value: <0.00195% CI: [34.8, 41.9]Generalized estimating equation model
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.
Time frame: Scheduled transmissions in the first month after enrollment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluation Group | Acute CareLink Transmission Success | 95.1 Percentage of completed transmissions |