Sinus Node DisfunctionNCT02976181
Brady MX a Quality Improvement Study
An observational study of Sinus Node Disfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in Mexico.
Trial summary
Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of IPG. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sinus Node Disfunction
- What is being tested?
- IPG
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 5 sitesMexico
- Study dates
- Dec 2016to Jun 2018
- How long will I take part?
- 6 Months
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bradycardia symptomatic patients
Who may be able to join
- Patient at least 18 years of age
- Patient´s heart rate meets at least one of the following:
- Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50 Patient has a history of exercise intolerance
- Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia)
- Patient (or patient´s legally authorized representative) is willing and able to sign and date written Patient Consent Form/Data Release Form
Who cannot join
- Patient has recent history of blood loss
- Patient has a medical history leading to suspicion of neurological disorder
- Patient has a history of Chronic Atrial Fibrilation
- Patient is enrolled or planing to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from Medtronic study manager
- Patient is not expected to survive 12 months
- Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mexico5 sites
Hospital General de Cancun
Cancún, Quintana Roo, 77524
Hospital Regional Universitario de Colima
Colima, 28019
Hospital General del Estado de Sonora
Hermosillo, Sonora, 83000
Hospital General de Queretaro
Querétaro, 76170
Hospital General de Tijuana
Tijuana, Estado de Baja California, 22000
About this study
Official title: Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)
Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of IPG.
- Conditions
- Sinus Node Disfunction
- Being tested
- IPG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPGDevice
Patient might require IPG device to be implanted under standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
Because the study intervention was not conducted, it is not possible to compare the proportion of subjects with an SND diagnosis pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of subjects with an SND diagnosis in Phase I are reported
Measured: 6 and 12 months
Secondary outcomes (1)
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
The change between subjects referred to an indicated IPG will be measured after the intervention in total number of patients that are referred correctly.
Because the study intervention was not conducted, it is not possible to compare the proportion of subjects receiving therapy referral for an indicated IPG pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of SND subjects receiving a referral for an indicated IPG device in Phase I are reported.
Measured: 3, 6, and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018
- Study completionJun 2018
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 Sinus Node DisfunctionStudies 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
- 113 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976181
- Sponsor's protocol ID
- Brady MX
- Status last verified
- Sep 2019
- First submitted
- 18 Jul 2016
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)
- ClinicalTrials.gov ID
- NCT02976181
- Acronym / sponsor ID
- Brady MX
- Conditions
- Sinus Node Disfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of IPG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bradycardia symptomatic patients
Key inclusion criteria (5 listed)
- Patient at least 18 years of age
- Patient´s heart rate meets at least one of the following:
- Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50 Patient has a history of exercise intolerance
- Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia)
- Patient (or patient´s legally authorized representative) is willing and able to sign and date written Patient Consent Form/Data Release Form
Key exclusion criteria (6 listed)
- Patient has recent history of blood loss
- Patient has a medical history leading to suspicion of neurological disorder
- Patient has a history of Chronic Atrial Fibrilation
- Patient is enrolled or planing to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from Medtronic study manager
- Patient is not expected to survive 12 months
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 |
|---|---|---|
| IPGPatient might require IPG device to be implanted under standard of care | Device | – |
Primary outcome
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
Time frame: 6 and 12 months
Because the study intervention was not conducted, it is not possible to compare the proportion of subjects with an SND diagnosis pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of subjects with an SND diagnosis in Phase I are reported
1 secondary outcome
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
Time frame: 3, 6, and 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus Node Disfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in Mexico.
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 5 inclusion and 6 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Mexico. 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 19 Sep 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?
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time. (time frame: 6 and 12 months). 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 19 Sep 2019.