Brady MX a Quality Improvement Study

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.	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

Secondary Outcome Measures

Name	Time	Method
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention	3, 6, and 15 months	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.

Locations (5): Hospital General del Estado de Sonora
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Hermosillo, Sonora, Mexico
Hospital General de Tijuana
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Tijuana, Baja California, Mexico
Hospital General de Cancun
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Cancún, Quintana Roo, Mexico
Hospital Regional Universitario de Colima
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Colima, Mexico
Hospital General de Queretaro
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Queretaro, Mexico