sutra hemi-valve first-in-human study

Conditions: Mitral Regurgitation

Summary: study to evaluate the feasibility, safety and performance of the sutra hemi-valve transcatheter mitral valve replacement system in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for surgical treatment.

investigational device: sutra transcatheter mitral valve replacement (tmvr) system the sutra hemi-valve tmvr system consists of 32fr delivery devices and an implantable hemi-valve. the sutra hemi-valve consists of a self-expanding nitinol frame, a tri-leaflet bovine pericardial hemi-valve, and a sealing skirt. the sutra hemi-valve is intended to replace the posterior leaflet of the mitral valve to treat mitral regurgitation. the frame consists of an atrial portion for anchoring to the native annulus, and a ventricular portion which houses the hemi-valve. the atrial section of the sutra hemi-valve contains three through-holes for anchoring to dual-guiding-and-fixation (dgf) devices implanted at the lateral trigone (t1), the medial trigone (t3), and in the center of the posterior annulus (p2). the sutra hemi-valve comes in two sizes: size 42 and size 38. intended use: the sutra hemi-valve tmvr system is intended for use as a partial replacement mitral valve. indication for use: the sutra hemi-valve tmvr system is indicated for use in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery. trial design: prospective, multi-center, unblinded, single arm first in human/ feasibility clinical study. primary objective: to assess the safety and performance of the sutra hemi-valve tmvr system in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery. secondary objectives: * improvement of mitral regurgitation * assess interaction of implant prosthesis with native mitral valve apparatus, conduction system, left ventricular outflow tract (lvot) and aortic valve * assess stability of implant. * assess hemodynamics of the mitral valve apparatus

Eligibility criteria:
inclusion criteria: * subject is greater than 18 years of age at time of enrollment. * subject has moderate-severe or severe symptomatic mitral regurgitation who are considered high surgical risk for conventional mitral repair or replacement, as assessed by institutional multidisciplinary heart team. * new york heart association (nyha) functional class ii and above. * subject anatomy is suitable for transfemoral and transeptal device delivery and meets sizing criteria for sutra hemi-valve tmvr system. * subject willing and able to provide informed consent and able to comply with the study protocol and follow up. * female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure exclusion criteria: * prohibitive mitral annular calcification * diseased mitral anterior leaflet such as flail or prolapse * previous mitral valve intervention * implanted with venous stents (iliac and femoral) including inferior vena cava (ivc) filter or congenital abnormalities of the ivc that would preclude ability for transfemoral access with the delivery system. * evidence of intra-cardiac, inferior vena cava (ivc) or ipsilateral femoral venous thrombus * severe aortic stenosis or insufficiency (note: may be treated ≥ 30 days prior to study procedure) * contraindication for transesophageal echocardiography (tee) or mdct scan * active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics) * endocarditis within 6 months * left ventricular ejection fraction (lvef) \< 25% * severe chronic obstructive pulmonary disease (copd) demonstrated by forced expiratory volume (fev1) \< 750cc * implant or revision of any pacing device \< 30 days prior to intervention * symptomatic coronary artery disease treated \< 30 days prior to study procedure * active peptic ulcer or upper gastrointestinal bleeding within 90 days * prior stroke, tia, or myocardial infarction within 90 days * severe renal insufficiency (creatinine \> 225 µmol/l) or patient requiring dialysis * any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment * pregnant, nursing or planning to be pregnant. (female participants of childbearing potential must have a negative pregnancy test prior to enrollment) * history of bleeding diathesis or coagulopathy that cannot be managed or patient will refuse blood transfusion * hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support * known hypersensitivity or contraindication to heparin and bivalirudin * known allergy to nitinol or contrast agents that cannot be pre-medicated * severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments. * patient is participating in another investigational drug or device clinical study that has not completed primary endpoint follow-up

Keywords: mitral regurgitation transcatheter mitral valve replacement transcatheter mitral valve repair hemi-valve