Overview
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.
Description
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
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