The Effects of Aortic Valve Replacement on Sleep Disordered Breathing, Heart Rate Variability and Ventricular Ectopy Burden in Patients with Severe Aortic Stenosis

Overview

  • Study type

    Observational
  • Study IDs

  • 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.
  • Site IRB
    • 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).

Participation eligibility

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:              

  • 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.

     

    Exclusion Criteria:            

  • 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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vuyisile Nkomo, M.D., M.P.H.

Closed for enrollment

Contact information:

Vuyisile Nkomo M.D., M.P.H.

(507)284-8612

nkomo.vuyisile@mayo.edu

More information

Study Progress

This study has completed enrollment of targeted participants and currently is completing research activities including study intervention, specimen collection, testing and data analysis.

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20317442

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