Trial Outcomes & Findings for BlueSync Field Evaluation (NCT NCT03518658)
NCT ID: NCT03518658
Last Updated: 2021-05-06
Results Overview
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.
COMPLETED
257 participants
Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation
2021-05-06
Participant Flow
Historical Controls were not considered enrolled in this study. The patients' data was extracted from Medtronic de-identified CareLink™ database.
Participant milestones
| Measure |
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
|
Control Group (Historical)
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
128607
|
|
Overall Study
COMPLETED
|
206
|
128607
|
|
Overall Study
NOT COMPLETED
|
51
|
0
|
Reasons for withdrawal
| Measure |
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
|
Control Group (Historical)
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
|
|---|---|---|
|
Overall Study
Other
|
51
|
0
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Evaluation Group
n=257 Participants
Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App
|
Control Group (Historical)
n=128607 Participants
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
|
Total
n=128864 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=257 Participants
|
50 Participants
n=128607 Participants
|
50 Participants
n=128864 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=257 Participants
|
26485 Participants
n=128607 Participants
|
26594 Participants
n=128864 Participants
|
|
Age, Categorical
>=65 years
|
148 Participants
n=257 Participants
|
102072 Participants
n=128607 Participants
|
102220 Participants
n=128864 Participants
|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 15.6 • n=257 Participants
|
72.2 years
STANDARD_DEVIATION 11.5 • n=128607 Participants
|
72.2 years
STANDARD_DEVIATION 11.5 • n=128864 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=257 Participants • 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.
|
61604 Participants
n=128256 Participants • 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.
|
61713 Participants
n=128513 Participants • 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.
|
|
Sex: Female, Male
Male
|
148 Participants
n=257 Participants • 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.
|
66652 Participants
n=128256 Participants • 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.
|
66800 Participants
n=128513 Participants • 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.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
152 Participants
n=257 Participants
|
128607 Participants
n=128607 Participants
|
128759 Participants
n=128864 Participants
|
|
Region of Enrollment
Italy
|
12 Participants
n=257 Participants
|
0 Participants
n=128607 Participants
|
12 Participants
n=128864 Participants
|
|
Region of Enrollment
United Kingdom
|
85 Participants
n=257 Participants
|
0 Participants
n=128607 Participants
|
85 Participants
n=128864 Participants
|
|
Region of Enrollment
France
|
8 Participants
n=257 Participants
|
0 Participants
n=128607 Participants
|
8 Participants
n=128864 Participants
|
|
Education
Less Than High School
|
17 Participants
n=257 Participants
|
NA Participants
n=128607 Participants
|
NA Participants
n=128864 Participants
|
|
Education
High School
|
111 Participants
n=257 Participants
|
NA Participants
n=128607 Participants
|
NA Participants
n=128864 Participants
|
|
Education
Bachelor
|
86 Participants
n=257 Participants
|
NA Participants
n=128607 Participants
|
NA Participants
n=128864 Participants
|
|
Education
Master
|
25 Participants
n=257 Participants
|
NA Participants
n=128607 Participants
|
NA Participants
n=128864 Participants
|
|
Education
PhD/Doctorate
|
18 Participants
n=257 Participants
|
NA Participants
n=128607 Participants
|
NA Participants
n=128864 Participants
|
PRIMARY outcome
Timeframe: Scheduled transmissions between 1 and 12 months after enrollment/CareLink activationTo 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.
Outcome measures
| Measure |
Evaluation Group
n=245 Participants
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
Of the 257 enrolled patients, one patient was not available in CareLink database, 4 patients left evaluation early which resulted in data loss, 5 patients had no transmissions scheduled between 1 and 12 months, and 2 subjects had scheduled transmissions completed with another monitor than MyCareLink Heart App.
|
Control Group (Historical)
n=128607 Participants
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
Control Group: Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C)
The enrolled patients in the evaluation were compared to a historical control group from the Medtronic de-identified CareLink™ database. The following inclusion criteria were used to select the analysis group from CareLink comparable to the BlueSync™ field evaluation : a) \> 18 years of age at implant; b) Patient activated (first received CareLink transmission with CareLink 2490 monitor) in CareLink from 1 Jan 2016 to 1 December 2018; c) Patient followed for at least one year after activation with a minimum of one scheduled transmission in this year, d) US patients, e) Patient did not perform transmission with another monitor for at least one year after activation.
|
Matched Control Group (Historical)
n=979 Participants
Individual matching was performed using a greedy algorithm to create a matched control group comparable to the evaluation group. The matched control subjects were chosen from the historical control group with low power implantable devices and CareLink Monitor 2490 (excluding 2490C monitor).
Subjects were matched exactly based on age (± 2 years), gender, and number of device chambers (single, dual or triple). For the evaluation group patients' age at screening was used while for the historical control cohort, age at implant was available. A range of two years was chosen since age at implant and age at screening should be within two years for the evaluation group with most patients having zero years between screening and implant.
|
|---|---|---|---|
|
Chronic CareLink Transmission Success
|
94.6 Percentage of completed transmissions
Interval 91.8 to 96.6
|
60.0 Percentage of completed transmissions
Interval 59.7 to 60.2
|
56.3 Percentage of completed transmissions
Interval 53.7 to 58.9
|
SECONDARY outcome
Timeframe: Scheduled transmissions in the first month after enrollmentPopulation: 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.
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.
Outcome measures
| Measure |
Evaluation Group
n=215 Participants
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
Of the 257 enrolled patients, one patient was not available in CareLink database, 4 patients left evaluation early which resulted in data loss, 5 patients had no transmissions scheduled between 1 and 12 months, and 2 subjects had scheduled transmissions completed with another monitor than MyCareLink Heart App.
|
Control Group (Historical)
Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C)
Control Group: Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C)
The enrolled patients in the evaluation were compared to a historical control group from the Medtronic de-identified CareLink™ database. The following inclusion criteria were used to select the analysis group from CareLink comparable to the BlueSync™ field evaluation : a) \> 18 years of age at implant; b) Patient activated (first received CareLink transmission with CareLink 2490 monitor) in CareLink from 1 Jan 2016 to 1 December 2018; c) Patient followed for at least one year after activation with a minimum of one scheduled transmission in this year, d) US patients, e) Patient did not perform transmission with another monitor for at least one year after activation.
|
Matched Control Group (Historical)
Individual matching was performed using a greedy algorithm to create a matched control group comparable to the evaluation group. The matched control subjects were chosen from the historical control group with low power implantable devices and CareLink Monitor 2490 (excluding 2490C monitor).
Subjects were matched exactly based on age (± 2 years), gender, and number of device chambers (single, dual or triple). For the evaluation group patients' age at screening was used while for the historical control cohort, age at implant was available. A range of two years was chosen since age at implant and age at screening should be within two years for the evaluation group with most patients having zero years between screening and implant.
|
|---|---|---|---|
|
Acute CareLink Transmission Success
|
95.1 Percentage of completed transmissions
Interval 92.0 to 97.0
|
—
|
—
|
Adverse Events
Evaluation Group
Control Group (Historical)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place