Brady MX a Quality Improvement Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02976181
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment
Sinus Node Disfunction Device: IPG

Study Type : Observational [Patient Registry]
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: IPG
    Patient might require IPG device to be implanted under standard of care

Primary Outcome Measures :
  1. Absolute change in the proportion of subjects diagnosed with SND at pre specific time. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of SND subjects receiving a referral for an indicated IPG device after the intervention [ Time Frame: 6 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bradycardia symptomatic patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02976181

Contact: Carina Leone +541148985737

Hospital General de Tijuana Recruiting
Tijuana, Baja California, Mexico, 22000
Contact: Guillermo Rivera, MD         
Principal Investigator: Guillermo Rivera, MD         
Hospital General de Cancun Recruiting
Cancún, Quintana Roo, Mexico, 77524
Contact: Fabiola Suarez, MD         
Principal Investigator: Fabiola Suarez, MD         
Hospital General del Estado de Sonora Recruiting
Hermosillo, Sonora, Mexico, 83000
Contact: Fulvio Bustamante, MD         
Principal Investigator: Fulvio Bustamante, MD         
Hospital Regional Universitario de Colima Recruiting
Colima, Mexico, 28019
Contact: Ulises Ramirez, MD         
Principal Investigator: Ulises Ramirez, MD         
Sub-Investigator: Vanessa Lam, MD         
Hospital General de Queretaro Recruiting
Queretaro, Mexico, 76170
Contact: Enrique Garcia, MD         
Principal Investigator: Enrique Garcia, MD         
Sub-Investigator: Linaloe Gonzalez         
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT02976181     History of Changes
Other Study ID Numbers: Brady MX
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes