BradycardiaNCT03518658
BlueSync Field Evaluation
An observational study of Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 20 sites in 4 countries.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Evaluation Group
- How many people
- 257 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 2 Apr 2018to 29 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at hospitals and clinics specializing in the implant and followup of pacemakers and CRT-P devices using remote monitoring
Who may be able to join
- 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
Who cannot join
- Patient unwilling to complete required surveys during 12-month evaluation period
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States11 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Mount Carmel
Columbus, Ohio, 43213
Daytona Heart Group
Daytona Beach, Florida, 32114
Cone Health
Greensboro, North Carolina, 27401
Hartford Hosital
Hartford, Connecticut, 06102
University of Kansas Medical Center
Kansas City, Kansas, 66160
East Tennessee Consultants
Knoxville, Tennessee, 37934
Cardiovascular Institutes of Orland0
Orlando, Florida, 32822
Stanford Universithy
Palo Alto, California, 94305
The Valley Hospital
Ridgewood, New Jersey, 07450
CentraCare
Saint Cloud, Minnesota, 56303
United Kingdom4 sites
Sandwell and West Birmingham Hospitals
Birmingham, B71 4HJ
Manchester Royal Infirmary
Manchester, M139WC
Southampton
Southampton, SO166YD
University Hospital of North Midlands NHS Trust
Stoke-on-Trent
Italy3 sites
Istituto clinico Città Studi
Milan
Ospedale Sacro Cuore
Negrar, 37024
Provincia Religiosa San Pietro Di Roma
Rome
About this study
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™.
Read the 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).
- Conditions
- Bradycardia
- Being tested
- Evaluation Group, Control Group (Historical)
- Keywords
- remote monitoring, transmission compliance, patient engagement
- Medical subject headings
- Bradycardia, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation GroupOther
Patient receiving exposure to the MyCareLink Heart App during device pairing
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation Group | Patients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App Receives: Other: Evaluation Group | |
| Control Group | Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C) Receives: Other: Control Group (Historical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation
Secondary outcomes (1)
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.
Measured: Scheduled transmissions in the first month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start2 Apr 2018
- Primary completion29 Dec 2019
- Study completion29 Dec 2019
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 BradycardiaStudies 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
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khaldoun Trajki, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518658
- Sponsor's protocol ID
- BlueSync Field Evaluation
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2018
- Last updated
- 6 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are not plans to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BlueSync Field Evaluation
- ClinicalTrials.gov ID
- NCT03518658
- Acronym / sponsor ID
- BlueSync Field Evaluation
- Conditions
- Bradycardia
- Keywords
- remote monitoring, transmission compliance, patient engagement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Posted 6 May 2021
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 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation Group | – | Other: Evaluation GroupPatients implanted with a pacemaker or CRT-P device who will be using remote monitoring via the MyCareLink Heart App |
| Control Group | – | Other: Control Group (Historical)Patients with low power implantable devices and CareLink Monitor 2490 (Excluding wireless model 2490C) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at hospitals and clinics specializing in the implant and followup of pacemakers and CRT-P devices using remote monitoring
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient unwilling to complete required surveys during 12-month evaluation period
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 |
|---|---|---|
| Evaluation GroupPatient receiving exposure to the MyCareLink Heart App during device pairing | Other | Evaluation Group |
| Control 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. | Other | Control Group |
Primary outcome
Chronic CareLink Transmission Success
Time frame: 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.
1 secondary outcome
Acute CareLink Transmission Success
Time frame: Scheduled transmissions in the first month after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are not plans to share IPD with other researchers
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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.
Khaldoun Trajki, MD principal investigator
The Cleveland Clinic
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 20 sites in 4 countries.
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 4 inclusion and 1 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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, United Kingdom, Italy, France. 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 6 May 2021). 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?
Chronic CareLink Transmission Success (time frame: Scheduled transmissions between 1 and 12 months after enrollment/CareLink activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.