Sinus Node Dysfunction
Conditions
Keywords
Sick Sinus Syndrome, Bradycardia
Brief summary
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Detailed description
The study is expected to provide evidence to support claim(s) that: * Education and process improvement initiatives can improve the diagnosis of and appropriate therapy application for sinus node dysfunction (SND) * The quality improvement methods studied have general applicability and can be used by all centers * Appropriate treatment minimizes caregiver burden * Appropriate treatment improves quality of life (QOL) and functional status compared to pre-implant
Interventions
BEHAVIORALEvidence based guidelines and tools
Education, guidelines, tools
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is 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/Patient Data Release Consent
Exclusion criteria
* Patient has type II 2nd degree AV block, High degree AV block (2:1, 3:1, 4:1 etc.) or 3rd degree AV block * 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 Fibrillation * Patient is enrolled or planning 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 the Medtronic study manager * Patient is not expected to survive for 12 months * Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 diagnosed with SND before and after intervention |
| The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Up to 6 months post diagnosis | Outcome measure applies to subjects that receive a SND diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | From date of SND diagnosis until date of therapy, assessed up to 6 months | Time to implant in days (date of implant - date of diagnosis) |
| The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy | Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy. |
| Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant | 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. |
| Difference in QoL Between Implant Visit and 6 Months Post-implant | 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. |
| Change in Time to Diagnosis of SND Before and After Intervention | From date of enrollment until date of SND diagnosis, assessed up to 60 months | Time to diagnosis days (date of diagnosis - date of enrollment) |
Countries
Argentina, Bangladesh, India, Mexico, Peru, Russia, Uruguay
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 823 |
| 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. | 470 |
| Total | 1,293 |
Baseline characteristics
| Characteristic | Phase I | Total | Phase II |
|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 16 | 59.3 years STANDARD_DEVIATION 15.6 | 57.9 years STANDARD_DEVIATION 14.9 |
| Race/Ethnicity, Customized Race/Ethnic Origin American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Asian | 59 Participants | 165 Participants | 106 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Hispanic or Latino | 163 Participants | 163 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Indian | 444 Participants | 789 Participants | 345 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Not reportable per local laws or regulations | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Other | 10 Participants | 29 Participants | 19 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Subject/Physician Chose not to provide information | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Two or More Races | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin Unknown/Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnic Origin White or Caucasian | 142 Participants | 142 Participants | 0 Participants |
| Sex: Female, Male Female | 277 Participants | 405 Participants | 128 Participants |
| Sex: Female, Male Male | 546 Participants | 888 Participants | 342 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 847 | 1 / 470 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: Up to 1 year post enrollment
Population: Only sites in South Asia participated in both Phase 1 and Phase 2, as such those subjects were included for objective analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 | The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | 368 Participants |
| Phase 2 | The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | 409 Participants |
p-value: <0.00001Chi-squared
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
Time frame: Up to 6 months post diagnosis
Population: Subjects with an SND diagnosis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 | The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | 63 Participants |
| Phase 2 | The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | 130 Participants |
p-value: <0.0001Chi-squared
Secondary
Change in Time to Diagnosis of SND Before and After Intervention
Time to diagnosis days (date of diagnosis - date of enrollment)
Time frame: From date of enrollment until date of SND diagnosis, assessed up to 60 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | 0 Months (or Prior to Enrollment) | 126 Participants |
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | Prior to 1 Month | 168 Participants |
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | 1-2 Months | 10 Participants |
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | 2-3 Months | 7 Participants |
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | 3-4 Months | 6 Participants |
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | 4-5 Months | 2 Participants |
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | 5-6 Months | 2 Participants |
| Phase 1 | Change in Time to Diagnosis of SND Before and After Intervention | Greater than 6 Months | 47 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | Greater than 6 Months | 4 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | 0 Months (or Prior to Enrollment) | 232 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | 3-4 Months | 1 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | Prior to 1 Month | 156 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | 5-6 Months | 2 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | 1-2 Months | 7 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | 4-5 Months | 3 Participants |
| Phase 2 | Change in Time to Diagnosis of SND Before and After Intervention | 2-3 Months | 4 Participants |
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)
Time frame: From date of SND diagnosis until date of therapy, assessed up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | Greater than 3 Months | 3 Participants |
| Phase 1 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | Prior to 1 Month | 37 Participants |
| Phase 1 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | 0 Months or Prior to Implant | 22 Participants |
| Phase 1 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | 1-2 Months | 1 Participants |
| Phase 1 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | 2-3 Months | 0 Participants |
| Phase 2 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | 1-2 Months | 0 Participants |
| Phase 2 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | 2-3 Months | 2 Participants |
| Phase 2 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | Greater than 3 Months | 2 Participants |
| Phase 2 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | 0 Months or Prior to Implant | 52 Participants |
| Phase 2 | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | Prior to 1 Month | 74 Participants |
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.
Time frame: between implant visit and 6 months post-implant
Population: Only subjects receiving a Medtronic device with both Implant and 6 Month data were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 | Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant | -14.7 change in score on Zarit QoL scale | Standard Deviation 15.7 |
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.
Time frame: between implant visit and 6 months post-implant
Population: Only subjects receiving a Medtronic device with both Implant and 6 Month data were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Difference in QoL Between Implant Visit and 6 Months Post-implant | SF-12 Physical Component | 11.7 difference of score on the SF-12 scale | Standard Deviation 8.1 |
| Phase 1 | Difference in QoL Between Implant Visit and 6 Months Post-implant | SF-12 Mental Component | 10.2 difference of score on the SF-12 scale | Standard Deviation 10.6 |
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.
Time frame: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
Population: Only subjects diagnosed in each phase with SND.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 | The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Subjects Diagnosed | 368 Participants |
| Phase 1 | The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Subjects Implanted | 63 Participants |
| Phase 2 | The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Subjects Diagnosed | 409 Participants |
| Phase 2 | The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Subjects Implanted | 130 Participants |
p-value: <0.0001Chi-squared