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Brady MX a Quality Improvement Study

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ClinicalTrials.gov Identifier: NCT02976181
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : September 6, 2018
Sponsor:
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]
Actual Enrollment : 113 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
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 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.



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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02976181


Locations
Mexico
Hospital General de Tijuana
Tijuana, Baja California, Mexico, 22000
Hospital General de Cancun
Cancún, Quintana Roo, Mexico, 77524
Hospital General del Estado de Sonora
Hermosillo, Sonora, Mexico, 83000
Hospital Regional Universitario de Colima
Colima, Mexico, 28019
Hospital General de Queretaro
Queretaro, Mexico, 76170
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02976181     History of Changes
Other Study ID Numbers: Brady MX
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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