Sutra Hemi-valve First-in-Human Study

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

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

Conditions2

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