N/A
N=113
Brady MX a Quality Improvement Study
Sinus Node Disfunction
Bottom Line
View on ClinicalTrials.gov: NCT02976181 ↗Enrolled (actual)
113
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time. — 69; 70 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- IPG (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time. |
69; 70 | — |
| SECONDARY Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention |
17; 18; 19; 51 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02976181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.