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Brady MX a Quality Improvement Study

Medtronic logo

Medtronic

Status

Completed

Conditions

Sinus Node Disfunction

Treatments

Device: IPG

Study type

Observational

Funder types

Industry

Identifiers

NCT02976181
Brady MX

Details and patient eligibility

About

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.

Enrollment

113 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Trial documents
1

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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