First use of the Sutra Hemi-valve for treating mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Waikato Hospital
  Hamilton, New Zealand Recruiting

Study contacts

• Study coordinator: Caitlin Martin, PhD
• Email: cmartin@sutramedical.com
• Phone: 949-317-3672

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.