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Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Overview

About this study

The purpose of this study is to compare the changes in quality of life following valve-invalve TAVR guided by Doppler-echocardiography vs. catheterization measurements.

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:

- Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team.

- Surgical stented bioprosthetic valve (label size ≤ 25 mm).

- TAVR with the SAPIEN 3 Ultra valve.

Exclusion Criteria:

- Stentless or sutureless surgical valves.

- Trifecta bioprosthesis.

- Hancock II bioprosthesis.

- High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT < 4 mm or based on the criterion of the heart team responsible for the procedure).

- Impossibility to obtain written informed consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/7/22. Questions regarding updates should be directed to the study team contact.

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.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

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CLS-20554436

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