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SQ-Kyrin-T First-in-man Feasibility Study

NCT06605313 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-09-20

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery; and to provide safety and efficacy data on which subsequent confirmatory trial can be based.

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System

Transcathether Edge-to-Edge repair for tricuspid regurgitation with SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System.

Sponsors & Collaborators

  • Shanghai Shenqi Medical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xiangbin Pan, MD, Ph.D · Fuwai Cardiovascular Hospital of Yunnan Province

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2022-12-07
Completion
2027-11-24

Countries

  • China

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 NCT06605313 on ClinicalTrials.gov