TVMR With The INNOVALVE System Trial - Early Feasibility Study

Overview

About this study

Study to evaluate the safety and performance of the INNOVALVE system

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\<25%

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

Eligibility last updated 10/24/2025. 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:

Carol Kerian Masters

5074222094

kerian-masters.carol@mayo.edu

More information

Publications

Publications are currently not available