Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06552689

Sutra Hemi-valve First-in-Human Study

Led by Sutra Medical, Inc. · Updated on 2025-03-17

15

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sutra Hemi-valve First-in-Human Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 64 7 days before the procedure
Not Eligible

You will not qualify if you...

  • 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 65 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 bcmol/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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Waikato Hospital

Hamilton, New Zealand, 3204

Actively Recruiting

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Research Team

C

Caitlin Martin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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