Tiara* Transcatheter Mitral Valve Replacement Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Age 18 years or older.
2. NYHA Class II to ambulatory Class IV.
3. Severe mitral regurgitation (reference Section 20)
4. High surgical risk for open mitral valve surgery as determined by the
examining cardiac surgeon and the local institutional Heart Team (consisting of
an interventional cardiologist and cardiac surgeon, at a minimum) based on an
STS mitral valve replacement PROM >=8% and/or the Heart Team assessing the risk
of operative mortality >=8% (modified from 2014 AHA/ACC Valvular Heart Disease
Guidelines definition of high risk).
5. Subject meets the initial anatomical eligibility criteria for annulus size
(site measurement of diameter <50 mm) for the available size(s) of the Tiara
Mitral Valve based on CT scan or TTE and/or TEE.
6. The subject has been informed of the nature of the investigational device,
required study follow-up procedures and visits and agrees to participate, and
has provided written informed consent.

Exclusion Criteria

1. Deemed too frail by objective frailty assessments or with severe
comorbidities such that the subject is unlikely to benefit from the procedure
as determined by the local institutional Heart Team.
2. Previous cardiac procedures:
a. PCI within 30 days of enrollment
b. Drug Eluting Stent implantation within 30 days of enrollment
c. Bare Metal Stent implantation within 30 days of enrollment
d. Coronary artery bypass graft (CABG) within 30 days of enrollment
e. Any surgical or transcatheter mitral valve replacement that would interfere
with the placement of the TiaraMitral Valve
f. TAVR within 30 days of enrollment
g. Mitral valve repair surgery within 30 days of enrollment
h. Cardiac transplant
i. CRT/ICD implant within 30 days of enrollment
3. Evidence of any myocardial infarction (MI) within 30 days of enrollment.
4. Cardiac structures:
a. Ventricular dysfunction with ejection fraction <= 25% within 30 days of
enrollment
b. Left ventricular outflow tract (LVOT) obstruction
c. Evidence of left atrial and/or left ventricular thrombus (within 90 days of
enrollment), vegetation or cardiac mass
d. Apex not amenable to transapical access as deemed by the examining cardiac
surgeon(s)
e. Aortic, tricuspid or pulmonary valve disease requiring intervention
f. Presence of a hemodynamically significant intracardiac shunt
g. Clinically significant untreated coronary artery disease (CAD) requiring
revascularization
5. Cerebrovascular accident (CVA) and/or transient ischemic attack (TIA) within
30 days of enrollment or Modified Rankin Scale >=4 disability.
6. Subjects who are on chronic dialysis or who have a serum creatinine value >
3.0 mg/dL (265.2 µmol) or eGFR < 35 ml/min within 30 days of enrollment.
7. Pregnant, currently breastfeeding, or planning pregnancy within next 12
months.
8. Documented bleeding or coagulation disorders which limit anticoagulant
therapy.
9. Documented recent (within 90 days of enrollment) GI bleeding requiring
medical intervention (e.g., blood transfusion).
10. Active infections requiring antibiotic therapy.
11. Known hypersensitivity or contraindication to:
a. Aspirin, or heparin, or clopidogrel (Plavix)
b. Allergy to contrast media which cannot be managed medically
c. Nitinol or its components (e.g., nickel or titanium)
12. Subject is unable to undergo transesophageal echocardiography (TEE) during
the implantation procedure.
13. Subject is currently participating in another investigational drug or
device clinical trial that may interfere with the results of either trial.
(Note: Patients
enrolled in a clinical trial involving products that are currently commercially
available are eligible).
14. Need for emergent or urgent surgery for any reason or any planned cardiac
surgery within the next 12 months.
15. Subjects with a life expectancy of less than 12 months due to noncardiac
reasons.
16. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic
support or mechanical hemodynamic support.
17. Subject is unable to complete study required screening procedures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Safety: Freedom from all-cause mortality and major adverse events defined<br /><br>as disabling stroke, myocardial infarction (peri-procedural or spontaneous),<br /><br>renal failure requiring dialysis, life-threatening bleeding, and cardiac<br /><br>surgical<br /><br>or transcatheter reintervention at 30 days from the implant procedure.<br /><br>• Device performance: The reduction of MR to optimal or acceptable at 30<br /><br>days. MR reduction is considered optimal when post-procedure MR is<br /><br>reduced to trace or absent. MR reduction is considered acceptable when<br /><br>post-procedure MR is reduced by at least 1 class or grade from baseline and<br /><br>to no more than moderate (2+) in severity.</p><br>

Secondary Outcome Measures