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Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
The study is expected to provide evidence to support claim(s) that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | Control | ||
| Phase II | Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evidence based guidelines and tools | Behavioral | Education, guidelines, tools |
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| Measure | Description | Time Frame |
|---|---|---|
| The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | The absolute change in the proportion of subjects diagnosed with SND before and after intervention | Up to 1 year post enrollment |
| The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Outcome measure applies to subjects that receive a SND diagnosis | Up to 6 months post diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy. | SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy |
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Inclusion Criteria:
Patient is at least 18 years of age
Patient's heart rate meets at least one of the following:
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/Patient Data Release Consent
Exclusion Criteria:
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Patients with possible sinus node dysfunction
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Agudos | Buenos Aires | Argentina | ||||
| National Heart Foundation Hospital and Research Institute |
Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice. In Phase 2, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I | Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice. |
| FG001 | Phase II | In Phase 2, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2012 | Sep 19, 2020 |
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| Change in Time to Diagnosis of SND Before and After Intervention | Time to diagnosis days (date of diagnosis - date of enrollment) | From date of enrollment until date of SND diagnosis, assessed up to 60 months |
| Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | Time to implant in days (date of implant - date of diagnosis) | From date of SND diagnosis until date of therapy, assessed up to 6 months |
| Difference in QoL Between Implant Visit and 6 Months Post-implant | The difference in quality of life was assessed using the SF-12 survey, with higher numbers indicating a better quality of life for the patient. The possible physical score ranges are between 24.0 and 56.6. The possible mental score ranges are between 19.1 and 60.8. Only the difference over time was reported. | between implant visit and 6 months post-implant |
| Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant | The difference in caregiver burden was assessed using a Zarit survey, with lower numbers indicating a decreased burden or a better outcome for the caregiver. The possible range of scores was between 0 and 88. Only the difference in scores over time were reported. | between implant visit and 6 months post-implant |
| Dhaka |
| Bangladesh |
| United Hospital Limited | Dhaka | Bangladesh |
| CARE Hospitals | Hyderabad | Andhra Pradesh | India |
| Care Insitute of Medical Sciences | Ahmedabad | Gujarat | India |
| RajaRajeswari Medical College & Hospital | Bangalore | Karnataka | India |
| Max Balaji Hospital | New Delhi | National Capital Territory of Delhi | India |
| Madras Medical Mission Institute of Cardiovascular Diseases | Chennai | Tamil Nadu | India |
| King George's Medical University | Lucknow | Uttar Pradesh | India |
| The Mission Hospital | Durgapur | West Bengal | India |
| Max Devki Devi Heart and Vascular Institute | Delhi | India |
| Centro Medico Nacional de Occidente IMSS | Mexico City | Mexico |
| Hospital Central Militar | Mexico City | Mexico |
| UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS | Mexico City | Mexico |
| Hospital Nacional Carlos Alberto Seguín Escobedo | Arequipa | Peru |
| Instituto Nacional Cardiovascular | Lima | Peru |
| Amur State Medical Academy | Amur | Amur Oblast | 675006 | Russia |
| Chelyabinsk Federal Center of Cardiovascular Surgery | Chelyabinsk | 454003 | Russia |
| Federal Center of Cardio-Vascular Surgery | Krasnoyarsk | 660020 | Russia |
| Center of Modern Cardiology | Krasnoyarsk | 660093 | Russia |
| Casa de Galicia | Montevideo | Uruguay |
| COMPLETED |
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| NOT COMPLETED |
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Phase 1, the control phase, we expect to obtain baseline measurements for key variables including the rate of SND diagnosis and the rate of implantation of an IPG in subjects with an SND diagnosis.2nd phase, the experimental phase, patients will have scheduled follow-up to collect questionnaire data if they are implanted with an IPG.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I | Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice. Phase I of the study was to understand the current pathways at hospital for SND patient screening & management. |
| BG001 | Phase II | In Phase II, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation. The toolkit included: a physician training seminar, a diagnostic algorithm, patient education materials, a list of available therapy options, and/or information regarding the benefits and risks associated with the therapy options. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | The absolute change in the proportion of subjects diagnosed with SND before and after intervention | Only sites in South Asia participated in both Phase 1 and Phase 2, as such those subjects were included for objective analysis. | Posted | Count of Participants | Participants | Up to 1 year post enrollment |
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| Primary | The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Outcome measure applies to subjects that receive a SND diagnosis | Subjects with an SND diagnosis | Posted | Count of Participants | Participants | Up to 6 months post diagnosis |
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| Secondary | The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy. | Only subjects diagnosed in each phase with SND. | Posted | Count of Participants | Participants | SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy |
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| Secondary | Change in Time to Diagnosis of SND Before and After Intervention | Time to diagnosis days (date of diagnosis - date of enrollment) | Posted | Count of Participants | Participants | From date of enrollment until date of SND diagnosis, assessed up to 60 months |
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| Secondary | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | Time to implant in days (date of implant - date of diagnosis) | Posted | Count of Participants | Participants | From date of SND diagnosis until date of therapy, assessed up to 6 months |
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| Secondary | Difference in QoL Between Implant Visit and 6 Months Post-implant | The difference in quality of life was assessed using the SF-12 survey, with higher numbers indicating a better quality of life for the patient. The possible physical score ranges are between 24.0 and 56.6. The possible mental score ranges are between 19.1 and 60.8. Only the difference over time was reported. | Only subjects receiving a Medtronic device with both Implant and 6 Month data were included | Posted | Mean | Standard Deviation | difference of score on the SF-12 scale | between implant visit and 6 months post-implant |
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| Secondary | Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant | The difference in caregiver burden was assessed using a Zarit survey, with lower numbers indicating a decreased burden or a better outcome for the caregiver. The possible range of scores was between 0 and 88. Only the difference in scores over time were reported. | Only subjects receiving a Medtronic device with both Implant and 6 Month data were included | Posted | Mean | Standard Deviation | change in score on Zarit QoL scale | between implant visit and 6 months post-implant |
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Study duration lasted 6 months
Adverse events beyond death were not collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I | Characterize the current management of patients presenting with possible sinus node dysfunction | 2 | 847 | 0 | 0 | 0 | 0 |
| EG001 | Phase II | Assess the effect of critical care pathways, education and comprehensive disease state management on the adoption of ACC/AHA/HRS and ESC indications and therapies for sinus node dysfunction. | 1 | 470 | 0 | 0 | 0 | 0 |
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Non-randomized observational study, data collected in a limited region with 10 specialized centers.Assumptions on the effect of pacemaker therapy affordability were limited.QoL increases were not compared to an age and gender-matched control group.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Clinical Research Program Manager | Medtronic | +1 (651) 308 3608 | jennifer.tinsley@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2018 | Jan 20, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not reportable per local laws or regulations |
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| American Indian or Alaska Native |
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| Asian |
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| Black or African American |
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| Hispanic or Latino |
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| Native Hawaiian or Pacific Islander |
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| White or Caucasian |
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| Indian |
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| Two or More Races |
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| Other |
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| Unknown/Not Reported |
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