Sutra Hemi-valve First-in-Human Study

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

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