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.
13.1 Inclusion Criteria
Patients must meet all of the following criteria to be considered for inclusion in this clinical
investigation:
1. 21 years of age or older.
2. Presence of severe degenerative mitral regurgitation with isolated mid-segment
posterior leaflet prolapse by echocardiographic study.
3. Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without
undue leaflet tension, based on the judgment of the Echocardiographic Core Lab.
4. Competent to sign informed consent and able to return for follow-up and is
capable of participating in all testing associated with this clinical investigation.
13.2 Exclusion Criteria
Patients will be excluded if any of the following criteria apply:
1. Functional mitral regurgitation (FMR).
2. Evidence of anterior or bileaflet prolapse.
3. Severe mitral annular calcification (MAC).
4. Moderate or greater leaflet calcification.
5. Fragile or thinning apex (e.g. LV aneurysm).
6. Have undergone cardiac or peripheral vascular procedures within 30 days prior to
the trial procedure.
7. Planned cardiac or peripheral vascular procedures within 30 days after the trial
procedure.
8. Requirement for concomitant cardiac surgery.
9. Severe pulmonary hypertension (pulmonary artery systolic pressure > 60mmHg).
10. Severe aortic stenosis or insufficiency.
11. Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid
regurgitation are not excluded.)
12. Left or right ventricular ejection fraction (LVEF or RVEF) <30% as measured by the
core lab.
13. Any history of endocarditis.
14. Contraindication to cardiac surgery, including hostile chest or history of
mediastinal radiation.
15. Previous structural heart intervention (e.g. any heart valve replacement or repair
procedures) with the exceptions of coronary artery bypass grafting (CABG) or
percutaneous coronary intervention (PCI).
16. Stroke within 30 days prior to index procedure.
17. ST segment elevation myocardial infarction (STEMI) requiring intervention within
30 days prior to index procedure.
18. Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, [or
MELD score of ≥ 13]).
20. Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g.
requiring inotropic support or mechanical support devices).
21. History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3000 mcL) or
acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL).
22. Refuse blood products.
23. Planned treatment with any other investigational device or procedure through 1-
year follow-up, or who are currently participating in an investigational drug or
device trial.
24. Carotid stenosis ≥ to 80% at time of enrollment.
25. Rheumatic heart disease including rheumatic mitral stenosis.
26. Pregnant or lactating at the time of enrollment (women of childbearing age
should have negative pregnancy test within 72 hours of surgery) or planning
pregnancy within the next 12 months.
27. Concurrent medical condition with a life expectancy of less than 12 months in the
judgment of the Investigator.
28. Condition or conditions that, in the opinion of the Investigator, precludes
participation, including willingness to comply with all follow-up procedures.
29. Contraindication for transesophageal echocardiography (TEE), including
esophageal spasm, esophageal stricture, esophageal laceration, esophageal
perforation, esophageal diverticula (e.g. Zenker's diverticulum).
30. Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or
appendage thrombus, myxoma, or vegetation).
31. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet
regimen.
Intra-operative exclusion criteria
32. No longer meets eligibility criteria based on intra-operative assessment.
19. Renal insufficiency CKD Stage 3b or worse (GFR < 45 ml/min/1.73 m2).