IPG
DevicePatient might require IPG device to be implanted under standard of care
NCT Number: NCT02976181
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.
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Notify Me18 year–90 year
All sexes
Observational
Hospital General de Tijuana, Tijuana, Estado de Baja California, Mexico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50 Patient has a history of exercise intolerance
Exclusion criteria
Patient might require IPG device to be implanted under standard of care
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
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.
Medtronic Cardiac Rhythm and Heart Failure
Industry
Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)
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.