NCT06552689 Sutra Hemi-valve First-in-Human Study

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 15 participants in total. It began in 2025-04 with a primary completion date of 2026-04.

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.

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

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