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De klinische studie NCT06552689 voor Mitralisklepregurgitatie is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Sutra Hemi-valve First-in-Human Study

Recruterend
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De klinische studie NCT06552689 is een interventioneel studie bij Mitralisklepregurgitatie met de status recruterend. Het doel is om 15 deelnemers te includeren vanaf 1 april 2025. De studie wordt geleid door Sutra Medical, Inc. en de voltooiing is gepland op 1 april 2026. Laatste update op ClinicalTrials.gov: 17 maart 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving

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
Officiële titel

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

Aandoeningen
Mitralisklepregurgitatie
Andere studie-ID's
  • CIP-002
NCT-ID
NCT06552689
Startdatum (Werkelijk)
2025-04
Laatste update geplaatst
2025-03-17
Verwachte einddatum
2026-04
Inschrijving (Geschat)
15
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
mitral regurgitation
transcatheter mitral valve replacement
transcatheter mitral valve repair
hemi-valve
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelSutra 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.
Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
Trans-septal Sutra Hemi-valve TMVR System to treat mitral regurgitation
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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

  • 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
Sutra Medical, Inc. logoSutra Medical, Inc.
Centraal Contactpersoon
Contact: Caitlin Martin, PhD, 949-317-3672, [email protected]
1 Studielocaties in 1 landen
Waikato Hospital, Hamilton, 3204, New Zealand
Simi Christudas Jayakumari, Contact, 078397136, [email protected]
Sanjeevan Pasupati, MD, Contact, 07 8398899, [email protected]
Sanjeevan Pasupati, MD, Hoofdonderzoeker
Recruterend