Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Overview
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 30, 2019
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
- Behavioral: Evidence based guidelines and tools
- Education, guidelines, tools
Arms, Groups and Cohorts
- Phase I
- Control
- Phase II
- Treatment
Clinical Trial Outcome Measures
Primary Measures
- The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
- Time Frame: 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
- Time Frame: Up to 6 months post diagnosis
- Outcome measure applies to subjects that receive a SND diagnosis
Secondary Measures
- The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
- Time Frame: 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 Time to Diagnosis of SND Before and After Intervention
- Time Frame: From date of enrollment until date of SND diagnosis, assessed up to 60 months
- Time to diagnosis days (date of diagnosis – date of enrollment)
- Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
- Time Frame: 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)
- Difference in QoL Between Implant Visit and 6 Months Post-implant
- Time Frame: 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 Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
- Time Frame: 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.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Provider of Information About this Clinical Study
- Sponsor
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