Sutra Hemi-valve First-in-Human Study
- Conditions
- Mitral Regurgitation
- Interventions
- Device: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
- Registration Number
- NCT06552689
- Lead Sponsor
- Sutra Medical, Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System The Sutra Hemi-valve TMVR System is an innovative approach developed as a treatment for mitral regurgitation consisting of the Sutra Hemi-valve posterior leaflet replacement device, and the 32 Fr trans-septal delivery system.
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days 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 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Waikato Hospital
🇳🇿Hamilton, New Zealand