The Effects of Aortic Valve Replacement on Sleep Disordered Breathing, Heart Rate Variability and Ventricular Ectopy Burden in Patients with Severe Aortic Stenosis
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 17-001309
Sponsor Protocol Number: 17-001309
About this study
Our overall goal is to determine whether the AVR improves SDB where present and sleep profiles (including sleepiness symptoms, quality of life and hypoxia).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.
Adults: >18 years
Patients with severe AS (valve area ≤1 cm2, mean gradient ≥40 mmHg, or peak velocity ≥4.0 m/s), or clinically severe aortic stenosis in the context of low-gradient and/or low ejection fraction.
Patients who have other significant valvular disease (warranting surgery or intervention)
Patients who have known SDB and have received treatment (current or active). Patients with a known diagnosis of SDB but have never received treatment are eligible.
Patients who are unable to consent
Children/adolescents under age 18 years
Pregnancy (women known to be pregnant)
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Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Publications are currently not available
Study Results Summary
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Supplemental Study Information
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