Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPG | Device | Patient might require IPG device to be implanted under standard of care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
Not provided
Not provided
Bradycardia symptomatic patients
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Tijuana | Tijuana | Estado de Baja California | 22000 | Mexico | ||
| Hospital General de Cancun |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm/Group Observational Registry | Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm/Group Observational Registry | Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Number of SND Diagnoses by Time to Diagnosis | Posted | Count of Participants | Participants | 6 and 12 months |
|
Adverse events were not collected in this study.
Adverse events were not collected in this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm/Group Observational Registry | Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy Adverse events were not collected in this study. There were no deaths reported in the study. |
Not provided
Not provided
No conclusions can be drawn from the amended analysis about whether educational interventions are able impact the clinical care pathway for bradycardia patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carina Leone, Latam CVG Trial Leader | Medtronic | +5411 5789 8521 | carina.leone@medtronic.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2016 | Jun 20, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| 3, 6, and 15 months |
| Cancún |
| Quintana Roo |
| 77524 |
| Mexico |
| Hospital General del Estado de Sonora | Hermosillo | Sonora | 83000 | Mexico |
| Hospital Regional Universitario de Colima | Colima | 28019 | Mexico |
| Hospital General de Queretaro | Querétaro | 76170 | Mexico |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Symptoms | Count of Participants | Participants |
|
| Cardiac and Vascular History | NYHA Classification: Stages of Heart Failure: Class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Count of Participants | Participants |
|
| Endocrine History | Count of Participants | Participants |
|
| Respiratory / Pulmonary History | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Because the study intervention was not conducted, it is not possible to compare the proportion of subjects receiving indicated therapy pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of SND subjects receiving indicated IPG therapy in Phase I are reported | Posted | Count of Participants | Participants | 3, 6, and 15 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| Title | Measurements |
|---|
|
| Not implanted |
|