NL-OMON41986
Completed
Not Applicable
A Clinical Study of the CardiAQ* Transcatheter Mitral Valve Implantation (TMVI) System<br>(Transapical Delivery System) - CardiAQ TMVI System
CardiAQ Valve Technologies, Inc.0 sites45 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- leaky heart valve
- Sponsor
- CardiAQ Valve Technologies, Inc.
- Enrollment
- 45
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. \* 65 years old.
- •2\. Willing and able to comply with all required follow\-up evaluations and assessments.
- •3\. Subject or authorized representative has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study.
- •Heart Failure Status
- •4\. New York Heart Associate Classification \* III
- •5\. Left Ventricular Ejection Fraction \* 30%.
- •6\. Mitral regurgitation (MR) \* Grade 3\+ (moderate/severe, or severe) using the AHA/ACC 2014 Guidelines for the Management of Patients with Valvular Heart Disease (as published in Circulation March 3, 2014\).
- •7\. STS mortality score \* 8% or determined to be high or extreme surgical risk by a Cardiac Surgeon.
- •8\. Hemodynamically stable while on heart failure medication for at least 30 days before the procedure.
- •9\. Left atrial height \* 4 cm.
Exclusion Criteria
- •1\. Currently participating in another investigational drug or device study.
- •2\. Need for emergent or urgent surgery for any reason.
- •3\. Any condition that, in the opinion of the Investigator, could interfere with Subject participation, confound the study results or interfere with study compliance.
- •4\. Lack of chordal support of the mitral valve (i.e., ruptured papillary muscle or secondary chords).
- •5\. Severe calcification of any component of the mitral valve, including one or both of the mitral leaflets.
- •6\. Myocardial infarction within the previous 6 weeks.
- •7\. Intra\-cardiac thrombus, mass or vegetation.
- •8\. Need for native aortic or pulmonic valve replacement.
- •Existing Co\-morbidities
- •9\. Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve.
Outcomes
Primary Outcomes
Not specified
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