Skip to main content
OpenTrials
Completed

NCT Number: NCT02976181

Brady MX a Quality Improvement Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Tijuana, Tijuana, Estado de Baja California, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPG

Device

Patient might require IPG device to be implanted under standard of care

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.