Clinical trial NCT06552689: Sutra Hemi-valve First-in-Human Study
Official title: First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients With Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Keywords: mitral regurgitation
transcatheter mitral valve replacement
transcatheter mitral valve repair
hemi-valve
Lead sponsor: Sutra Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days
timeFrame: Day 30
measure: Primary Performance Endpoint - Sutra Hemi-valve TMVR System Technical Success
timeFrame: Day 0
Secondary outcomes:
measure: Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).
timeFrame: Day 0
measure: 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).
timeFrame: Day 0 - Day 7
measure: MR severity grade per Echo
timeFrame: Day 30, Month 6, Month 12
measure: Change in NYHA functional class
timeFrame: Day 30, Month 6, Month 12
measure: 6 Minute Walk Test distance (6MWT)
timeFrame: Day 30, Month 6, Month 12
Other outcomes:
measure: Change in LV ejection fraction
timeFrame: Day 30, Month 6, Month 12
measure: Change in LV end diastolic volume index (LVEDVI)
timeFrame: Day 30, Month 6, Month 12
measure: Change in LV end systolic volume index (LVESVI)
timeFrame: Day 30, Month 6, Month 12
measure: Change in LV stroke volume
timeFrame: Day 30, Month 6, Month 12
measure: Heart failure hospitalizations
timeFrame: Day 30, Month 6, Month 12
measure: Number of days alive and out of hospital
timeFrame: Day 30, Month 6, Month 12
Locations:
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
References: