Sutra Hemi-valve First-in-Human Study

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation

In brief

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.

Key facts

Study ID

NCT06552689

Run by

Sutra Medical, Inc.

People needed

15

Starts

2025-04-01

Expected to finish

2026-04-01

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Waikato Hospital — Hamilton, New Zealand (enrolling)

Full record on ClinicalTrials.gov

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