Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

Study Overview
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Brief Summary
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Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

Detailed Description
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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

Official Title
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Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

Conditions
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Sinus Node Dysfunction

Intervention / Treatment
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* Behavioral: Evidence based guidelines and tools


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase I<br>Control | |
| Phase II<br>Treatment | Behavioral: Evidence based guidelines and tools<br>* Education, guidelines, tools<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bradycardia, Sick Sinus Syndrome