Standard Bradycardia Pacing IndicationBRADYCARE IINCT02577887
Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
An observational study of Standard Bradycardia Pacing Indication, run by Abbott Medical Devices at 4 sites in 4 countries.
Trial summary
The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Standard Bradycardia Pacing Indication
- What is being tested?
- Patients implanted with a St. Jude Medical pacemakers
- Type of treatment
- Medical device
- How many people
- 2,101 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2015to 15 Dec 2017
- How long will I take part?
- 1 Year
- 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 with a standard bradycardia pacing indication and implanted with a St. Jude Medical pacemaker
Who may be able to join
- Patients who have been implanted with an SJM Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the EMEA region within 30 days or patients implanted with an Accent MRI™, Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the Asia-Pac region within 30 days.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Patient is not pregnant or planning to become pregnant during the course of the study.
- Patient is > 18 years of age
Who cannot join
- Patient's life expectancy is less than 1 year
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.
Read the detailed description
The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers.
The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.
- Conditions
- Standard Bradycardia Pacing Indication
- Being tested
- Patients implanted with a St. Jude Medical pacemakers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients implanted with a St. Jude Medical pacemakersDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complications in the General Pacemaker Population
The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.
Measured: 1 year
Secondary outcomes (3)
Number of Subjects Programmed With Advanced Pacemaker Features
Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features.
Measured: 1 year
Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features.
Measured: 1 year
Number of MRI Scans by Country
The total number of scans performed by country
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJul 2015
- Primary completion25 Nov 2017
- Study completion15 Dec 2017
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 Standard Bradycardia Pacing IndicationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 2,101 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant Kim, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577887
- Sponsor's protocol ID
- SJM-CIP-10073
- Acronym
- BRADYCARE II
- Status last verified
- Feb 2020
- First submitted
- 6 Oct 2015
- Last updated
- 9 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
- ClinicalTrials.gov ID
- NCT02577887
- Acronym / sponsor ID
- BRADYCARE II / SJM-CIP-10073
- Conditions
- Standard Bradycardia Pacing Indication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,101 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 25 Nov 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 18 Nov 2019
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 study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.
Detailed description
The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers.
The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a standard bradycardia pacing indication and implanted with a St. Jude Medical pacemaker
Key inclusion criteria (4 listed)
- Patients who have been implanted with an SJM Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the EMEA region within 30 days or patients implanted with an Accent MRI™, Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the Asia-Pac region within 30 days.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Patient is not pregnant or planning to become pregnant during the course of the study.
- Patient is > 18 years of age
Key exclusion criteria (1 listed)
- Patient's life expectancy is less than 1 year
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 |
|---|---|---|
| Patients implanted with a St. Jude Medical pacemakers | Device | – |
Primary outcome
Percentage of Participants With Complications in the General Pacemaker Population
Time frame: 1 year
The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.
3 secondary outcomes
Number of Subjects Programmed With Advanced Pacemaker Features
Time frame: 1 year
Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
Time frame: 1 year
Number of MRI Scans by Country
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Grant Kim study director
Abbott Medical Devices
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Standard Bradycardia Pacing Indication, run by Abbott Medical Devices at 4 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Italy, Japan. 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 18 Nov 2019). 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?
Percentage of Participants With Complications in the General Pacemaker Population (time frame: 1 year). 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 9 Mar 2020.