Sutra Hemi-valve First-in-Human Study

First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients with Mitral Regurgitation

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin Martin, PhD; Phone Number: 949-317-3672; Email: cmartin@sutramedical.com

Study Locations

• New Zealand
  • Hamilton, New Zealand, 3204
    • Recruiting
    • Waikato Hospital
    • Contact: Simi Christudas Jayakumari; Phone Number: 078397136; Email: Simi.ChristudasJayakumari@waikatodhb.health.nz
    • Contact: Sanjeevan Pasupati, MD; Phone Number: 07 8398899; Email: drspasupati@gmail.com
    • Contact: Sanjeevan Pasupati, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR); 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.	Device: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System; Trans-septal Sutra Hemi-valve TMVR System to treat mitral regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days	including: Death (Cardiovascular mortality vs non-cardiovascular);; Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications;; Disabling stroke;; Myocardial infarction (MVARC);; Major access site and vascular complications;; Fatal or life-threatening bleeding (MVARC Type III-V);; Renal Failure requiring dialysis;; Cardiac tamponade.	Day 30
Primary Performance Endpoint - Sutra Hemi-valve TMVR System Technical Success	defined as: successful access, delivery, and retrieval of the delivery system; and successful deployment and correct positioning of the implant; and no need for additional emergency surgery or re-intervention related to the investigational device or index procedure.	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).	Day 0
Post-index procedure (discharge or within 7 Days post-index procedure, whichever is earliest) MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).	Day 0 - Day 7
MR severity grade per Echo	Day 30, Month 6, Month 12
Change in NYHA functional class	Day 30, Month 6, Month 12
6 Minute Walk Test distance (6MWT)	Day 30, Month 6, Month 12

Other Outcome Measures

Outcome Measure	Time Frame
Change in LV ejection fraction	Day 30, Month 6, Month 12
Change in LV end diastolic volume index (LVEDVI)	Day 30, Month 6, Month 12
Change in LV end systolic volume index (LVESVI)	Day 30, Month 6, Month 12
Change in LV stroke volume	Day 30, Month 6, Month 12
Heart failure hospitalizations	Day 30, Month 6, Month 12
Number of days alive and out of hospital	Day 30, Month 6, Month 12

Collaborators and Investigators

• Sponsor: Sutra Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: mitral regurgitation; transcatheter mitral valve repair; transcatheter mitral valve replacement; hemi-valve
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CIP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No