Brady MX a Quality Improvement Study

Sinus Node Disfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976181
• Other study ID #: Brady MX
• Status: Completed
• Start date: December 2016
• Est. completion date: June 2018

Study information

• Verified date: September 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Sick Sinus Syndrome
• Sinus Node Disfunction

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital General de Cancun	Cancún	Quintana Roo
Mexico	Hospital Regional Universitario de Colima	Colima
Mexico	Hospital General del Estado de Sonora	Hermosillo	Sonora
Mexico	Hospital General de Queretaro	Queretaro
Mexico	Hospital General de Tijuana	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.	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	6 and 12 months
Secondary	Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention	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.	3, 6, and 15 months