Mitral Regurgitation
Conditions
Keywords
mitral regurgitation, transcatheter mitral valve replacement, transcatheter mitral valve repair, hemi-valve
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
Interventions
DEVICESutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
Trans-septal Sutra Hemi-valve TMVR System to treat mitral regurgitation
Sponsors
Sutra Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate). | Day 0 |
| 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 |
| MR severity grade per Echo | Day 30, Month 6, Month 12 |
| Change in NYHA functional class | Day 30, Month 6, Month 12 |
| 6 Minute Walk Test distance (6MWT) | Day 30, Month 6, Month 12 |
Other
| Measure | Time frame |
|---|---|
| Change in LV end diastolic volume index (LVEDVI) | Day 30, Month 6, Month 12 |
| Change in LV ejection fraction | Day 30, Month 6, Month 12 |
| Change in LV end systolic volume index (LVESVI) | Day 30, Month 6, Month 12 |
| Change in LV stroke volume | Day 30, Month 6, Month 12 |
| Heart failure hospitalizations | Day 30, Month 6, Month 12 |
| Number of days alive and out of hospital | Day 30, Month 6, Month 12 |
Countries
New Zealand
Contacts
Primary ContactCaitlin Martin, PhD
Outcome results
None listed