Expanded Clinical Study of Tendyne Mitral Valve System

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

Subjects must meet ALL of the following criteria:
1. Severe mitral regurgitation of primary or secondary etiology.
2. New York Heart Association (NYHA) functional Class >= II. If Class IV,
patient must be ambulatory.
3. Heart team determines patient is not a suitable candidate for traditional
surgical treatment.
4. Age 18 years or older.

Exclusion Criteria

Subjects will be excluded if any of the following criteria are met:
1. Severe mitral annular calcification, severe mitral stenosis, valvular
vegetation or mass.
2. Left Ventricle (LV) or Left Atrium (LA) thrombus.
4. Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
5. Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.
6. Prior surgical or interventional treatment of mitral or aortic valves
9. Myocardial Infarction (MI) within 30 days of the planned implant procedure.
10. Symptomatic, unresolved multi-vessel or unprotected left main coronary
artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).
12. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
14. Severe tricuspid regurgitation or severe right ventricular dysfunction.
15. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or
any other structural heart disease causing heart failure other than dilated
cardiomyopathy of either ischemic or non-ischemic etiology.
17. History of endocarditis within six months of planned implant procedure.
21. Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>There are no pre-defined pass or fail criteria for evaluating the study<br /><br>objectives. Endpoints were selected to enable the sponsor, its safety<br /><br>committees, and regulatory agencies the ability to compare estimates obtained<br /><br>from this study to estimates from studies of other comparable procedures and<br /><br>devices. Objectives and endpoints were selected based on input from medical<br /><br>advisors experienced in related procedures and studies of other replacement<br /><br>valves and devices used to treat mitral regurgitation.</p><br>

Secondary Outcome Measures