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Sutra Hemi-valve First-in-Human Study

NCT06552689 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-17

No results posted yet for this study

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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • Sutra Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552689 on ClinicalTrials.gov