Brady MX a Quality Improvement Study

Study Overview
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Brief Summary
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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.

Official Title
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Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)

Conditions
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Sinus Node Disfunction

Intervention / Treatment
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* Device: IPG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: IPG|Patient might require IPG device to be implanted under standard of care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3, 6, and 15 months |