Invasive Hemodynamic Response in Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement

Overview

About this study

The purpose of this study is to compare the hemodynamic effects of Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults (age ≥ 40 years)
  • Severe, symptomatic valvular aortic stenosis identified by Doppler transthoracic echocardiogram defined as:
    • AVA < 1.0 cm2, OR
    • AVA index <0.6 cm2/m2, OR
    • Peak AV jet velocity ≥ 4 m/s, OR
    • Mean resting gradient > 40 mmHg
  • Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for transfemoral TAVR.
  • TAVR procedure must be performed in the cardiac catheterization laboratory for hemodynamic data recording

Exclusion Criteria:

  • Patients who do not have adequate ileofemoral arteries for a transfemoral approach and require an alternative access (transapical, transaortic or transubclavian).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Closed for enrollment

Contact information:

Dawn Shelstad

(507)255-0473

shelstad.dawn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20308045

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