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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06552689




Registration number
NCT06552689
Ethics application status
Date submitted
6/08/2024
Date registered
14/08/2024

Titles & IDs
Public title
Sutra Hemi-valve First-in-Human Study
Scientific title
First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients with Mitral Regurgitation
Secondary ID [1] 0 0
CIP-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System

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.


Treatment: Devices: Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
Trans-septal Sutra Hemi-valve TMVR System to treat mitral regurgitation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days
Timepoint [1] 0 0
Day 30
Primary outcome [2] 0 0
Primary Performance Endpoint - Sutra Hemi-valve TMVR System Technical Success
Timepoint [2] 0 0
Day 0
Secondary outcome [1] 0 0
Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 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).
Timepoint [2] 0 0
Day 0 - Day 7
Secondary outcome [3] 0 0
MR severity grade per Echo
Timepoint [3] 0 0
Day 30, Month 6, Month 12
Secondary outcome [4] 0 0
Change in NYHA functional class
Timepoint [4] 0 0
Day 30, Month 6, Month 12
Secondary outcome [5] 0 0
6 Minute Walk Test distance (6MWT)
Timepoint [5] 0 0
Day 30, Month 6, Month 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sutra Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Caitlin Martin, PhD
Address 0 0
Country 0 0
Phone 0 0
949-317-3672
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06552689