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Sutra Hemi-valve First-in-Human Study

S

Sutra Medical, Inc.

Status

Begins enrollment this month

Conditions

Mitral Regurgitation

Treatments

Device: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06552689
CIP-002

Details and patient eligibility

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.

Full description

Investigational Device:

Sutra Transcatheter Mitral Valve Replacement (TMVR) System The Sutra Hemi-valve TMVR System consists of 32Fr delivery devices and an implantable hemi-valve.

The Sutra Hemi-valve consists of a self-expanding nitinol frame, a tri-leaflet bovine pericardial hemi-valve, and a sealing skirt. The Sutra Hemi-valve is intended to replace the posterior leaflet of the mitral valve to treat mitral regurgitation. The frame consists of an atrial portion for anchoring to the native annulus, and a ventricular portion which houses the Hemi-valve. The atrial section of the Sutra Hemi-valve contains three through-holes for anchoring to Dual-guiding-and-fixation (DGF) devices implanted at the lateral trigone (T1), the medial trigone (T3), and in the center of the posterior annulus (P2). The Sutra Hemi-valve comes in two sizes: Size 42 and Size 38.

Intended Use: The Sutra Hemi-valve TMVR system is intended for use as a partial replacement mitral valve.

Indication for Use: The Sutra Hemi-valve TMVR system is indicated for use in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery.

Trial Design: Prospective, multi-center, unblinded, single arm first in human/ feasibility clinical study.

Primary Objective:

To assess the safety and performance of the Sutra Hemi-valve TMVR System in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery.

Secondary Objectives:

  • Improvement of mitral regurgitation
  • Assess interaction of implant prosthesis with native mitral valve apparatus, conduction system, left ventricular outflow tract (LVOT) and aortic valve
  • Assess stability of implant.
  • Assess hemodynamics of the mitral valve apparatus

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR)
Experimental group
Description:
The Sutra Hemi-valve TMVR System is an innovative approach developed as a treatment for mitral regurgitation consisting of the Sutra Hemi-valve posterior leaflet replacement device, and the 32 Fr trans-septal delivery system.
Treatment:
Device: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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