Sutra Hemi-valve First-in-Human Study

Launched by SUTRA MEDICAL, INC. · Aug 9, 2024

Keywords

ClinConnect Summary

The Sutra Hemi-valve First-in-Human Study is a clinical trial aimed at testing a new device called the Sutra Hemi-valve, designed for patients with moderate to severe mitral regurgitation. This condition means that the heart's mitral valve doesn’t close properly, causing blood to leak backward into the heart. The study is specifically for patients who are experiencing significant symptoms and are considered too high-risk for traditional surgical treatments. If you are 18 years or older, have been diagnosed with this heart condition, and meet other specific health criteria, you might be eligible to participate in the trial.

Participants in this study will undergo a procedure to receive the Sutra Hemi-valve, and their safety and how well the device works will be closely monitored. The trial is currently recruiting patients, and those who join will need to provide their consent and commit to follow-up appointments. It's important to note that there are some health conditions that would exclude someone from participating, such as severe heart or lung problems, certain previous treatments, or active infections. This study represents a promising opportunity for patients who have few treatment options due to their high surgical risk.

Gender

ALL

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%
• • 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