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Mitral RegurgitationNCT06552689

Sutra Hemi-valve First-in-Human Study

A study testing Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System in people with Mitral Regurgitation, run by Sutra Medical, Inc. at 1 site in New Zealand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Regurgitation
What is being tested?
Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteNew Zealand
Study dates
Apr 2025to Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 24Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Caitlin Martin, PhD contact

949-317-3672

cmartin@sutramedical.com

New Zealand1 site, 1 recruiting

  • Waikato Hospital

    Hamilton, 3204

    Simi Christudas Jayakumari, 078397136, Simi.ChristudasJayakumari@waikatodhb.health.nz

    Sanjeevan Pasupati, MD, 07 8398899, drspasupati@gmail.com

    Recruiting

Other trials in New Zealand

About this study

Official title: 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.

Read the 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
Being tested
Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
Keywords
mitral regurgitation, transcatheter mitral valve replacement, transcatheter mitral valve repair, hemi-valve
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) SystemDevice

    Trans-septal Sutra Hemi-valve TMVR System to treat mitral regurgitation

Study groups in NCT06552689
Study groupRoleWhat they receive
Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR)ExperimentalThe 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.
Receives: Device: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 30

  2. 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.

    Measured: Day 0

Secondary outcomes (5)

  1. Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).

    Measured: Day 0

  2. 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).

    Measured: Day 0 - Day 7

  3. MR severity grade per Echo

    Measured: Day 30, Month 6, Month 12

  4. Change in NYHA functional class

    Measured: Day 30, Month 6, Month 12

  5. 6 Minute Walk Test distance (6MWT)

    Measured: Day 30, Month 6, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study startApr 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06552689
Sponsor's protocol ID
CIP-002
Status last verified
Mar 2025
First submitted
6 Aug 2024
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System in people with Mitral Regurgitation, run by Sutra Medical, Inc. at 1 site in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caitlin Martin, PhD (949-317-3672, cmartin@sutramedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days (time frame: Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06552689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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