Sutra Hemi-valve First-in-Human Study

NCT06552689 | Recruiting

• 1 other identifier: CIP-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation

Keywords

mitral regurgitation; transcatheter mitral valve replacement; transcatheter mitral valve repair; hemi-valve

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 Outcomes (6)

• 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

Study Arms (1)

Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR)

EXPERIMENTAL

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

Interventions

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

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

Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutra Medical, Inc.: lead

Study Sites (1)

Waikato Hospital

Hamilton, 3204, New Zealand

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Caitlin Martin, PhD

CONTACT

949-317-3672; cmartin@sutramedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 14, 2024
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)