Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Overview

About this study

Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

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:

- 18 years or older at the time of informed consent

- Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery

- Provides written informed consent

- Willingness to follow protocol requirements

Exclusion Criteria:

- Active endocarditis 3 months prior to the procedure

- Stage 4 renal disease or requiring dialysis

- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease

- High predicted risk of mortality prior to procedure

- Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of > 8 or

- Surgeon estimated risk of mortality of > 8

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

Eligibility last updated 5/22/23. 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 Gabor Bagameri, M.D.	Closed for enrollment	Contact information: Lukman Tata CCRP (507) 255-4158 Tata.Lukman@mayo.edu
Eau Claire, Wis. Mayo Clinic principal investigator Gabor Bagameri, M.D.	Closed for enrollment	Contact information: Rebecca Schmidt M.S.N., R.N. (715) 838-5137 Schmidt.Rebecca2@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gabor Bagameri, M.D.

Closed for enrollment

Contact information:

Lukman Tata CCRP

(507) 255-4158

Tata.Lukman@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Gabor Bagameri, M.D.

Closed for enrollment

Contact information:

Rebecca Schmidt M.S.N., R.N.

(715) 838-5137

Schmidt.Rebecca2@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials