TVMR With the Innovalve System Trial - Early Feasibility Study


About this study

The purpose of this study is to assess the technical and procedural success of the Innovalve TMVR system when used to treat adult patients with symptomatic moderate-severe and severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for a transfemoral catheterization with transseptal approach to the left atrium.



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:

- Clinically significant, symptomatic mitral regurgitation.

- High risk for open-heart surgery.

- Meets anatomical criteria.

Exclusion Criteria:

- Unsuitable anatomy.

- Patient is inoperable.

- EF< 30%.

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

Eligibility last updated 9/15/22. 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

Charanjit Rihal, M.D.

Open for enrollment

Contact information:

Carol Kerian Masters R.N.

(507) 422-2094

More information


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