Brady MX a Quality Improvement Study

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.

Study Overview

• Status: Completed
• Conditions: Sinus Node Disfunction
• Intervention / Treatment: Device: IPG

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• Mexico
  • Colima, Mexico, 28019
    • Hospital Regional Universitario de Colima
  • Queretaro, Mexico, 76170
    • Hospital General de Queretaro
  • Baja California
    • Tijuana, Baja California, Mexico, 22000
      • Hospital General de Tijuana
  • Quintana Roo
    • Cancún, Quintana Roo, Mexico, 77524
      • Hospital General de Cancun
  • Sonora
    • Hermosillo, Sonora, Mexico, 83000
      • Hospital General del Estado de Sonora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Bradycardia symptomatic patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Sick Sinus Syndrome
• Other Study ID Numbers: Brady MX