SQ-Kyrin-T First-in-man Feasibility Study (NCT06605313) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SQ-Kyrin-T First-in-man Feasibility Study
China12 participantsStarted 2022-06-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Severe or greater (≥3+) tricuspid regurgitation determined by transthoracic echocardiogram despite adequate treatment per applicable standards.
✓. NYHA classification of II, III, or IVa.
✓. Age ≥ 18 years old, gender not limited.
✓. Patient is determined to be at high or prohibitive risk for tricuspid valve surgery, or is determined to be not suitable for open heart surgery by local multidisciplinary cardiac team (with at least one cardiac surgeon and one cardiologist).
✓. Patients who understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo relevant examinations and clinical follow-up.
✓. Tricuspid valve coaptation defect\<2cm.
✓. No significant calcification of tricuspid valve leaflets.
✓. Tricuspid valve leaflet anatomy suitable for clip implantation, positioning on the leaflets and sufficient reduction in TR.