First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients with Mitral Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Sutra Medical, Inc.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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
Investigators
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%
Outcomes
Primary Outcomes
Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days
Time Frame: Day 30
including: * Death (Cardiovascular mortality vs non-cardiovascular); * Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; * Disabling stroke; * Myocardial infarction (MVARC); * Major access site and vascular complications; * Fatal or life-threatening bleeding (MVARC Type III-V); * Renal Failure requiring dialysis; * Cardiac tamponade.
Primary Performance Endpoint - Sutra Hemi-valve TMVR System Technical Success
Time Frame: Day 0
defined as: successful access, delivery, and retrieval of the delivery system; and successful deployment and correct positioning of the implant; and no need for additional emergency surgery or re-intervention related to the investigational device or index procedure.
Secondary Outcomes
- 6 Minute Walk Test distance (6MWT)(Day 30, Month 6, Month 12)
- Change in NYHA functional class(Day 30, Month 6, Month 12)
- Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).(Day 0)
- MR severity grade per Echo(Day 30, Month 6, Month 12)
- Post-index procedure (discharge or within 7 Days post-index procedure, whichever is earliest) MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).(Day 0 - Day 7)