First use of the Sutra Hemi-valve for treating mitral regurgitation
First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients With Mitral Regurgitation
This study is testing a new heart valve replacement device to see if it can safely help people with severe mitral regurgitation who can't have traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sutra Medical, Inc. Industry-sponsored |
| Locations | 1 site (Hamilton) |
| Trial ID | NCT06552689 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients suffering from moderate-severe to severe symptomatic mitral regurgitation who are at high risk for traditional surgical interventions. The Sutra Hemi-valve is designed to partially replace the mitral valve by addressing the posterior leaflet, utilizing a self-expanding nitinol frame and a tri-leaflet bovine pericardial valve. The trial is a prospective, multi-center, unblinded, single-arm feasibility study aimed at assessing the device's effectiveness in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with moderate-severe or severe symptomatic mitral regurgitation who are deemed high risk for conventional surgery.
Not a fit: Patients with significant mitral annular calcification or those with previous mitral valve interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with high surgical risk, potentially improving their quality of life.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in transcatheter valve replacements, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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% * 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
Where this trial is running
Hamilton
- Waikato Hospital — Hamilton, New Zealand (Recruiting)
Study contacts
- Study coordinator: Caitlin Martin, PhD
- Email: cmartin@sutramedical.com
- Phone: 949-317-3672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.