Status:
ACTIVE_NOT_RECRUITING
SQ-Kyrin-T First-in-man Feasibility Study
Lead Sponsor:
Shanghai Shenqi Medical Technology Co., Ltd
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
A prospective, multicenter, single-arm feasibility trial to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Previous tricuspid valve surgery; previous heart transplant; implanted cardiac electronic device.
- Any cardiovascular interventional procedure within the past 30 days.
- Patients with other valvular diseases requiring surgical or interventional treatment.
- Patients with severe large-vessel disease requiring surgical treatment.
- Echocardiogram indicating the presence of intracardiac masses, thrombus, or vegetations.
- Severe uncontrolled hypertension (systolic blood pressure \[SBP\] ≥ 180 mmHg and/or diastolic blood pressure \[DBP\] ≥ 110 mmHg).
- Pulmonary artery systolic pressure \> 70 mmHg.
- Moderate to severe or severe mitral regurgitation (≥3+).
- Active infective endocarditis, active rheumatic heart disease, or rheumatic tricuspid valve disease.
- Myocardial infarction or known unstable angina within the past 30 days.
- Severe untreated coronary artery disease.
- Hemodynamic instability, defined as SBP \< 90 mmHg with or without cardiogenic shock, or the need for an intra-aortic balloon pump or other hemodynamic support device.
- Cerebrovascular accident within the past 3 months.
- Renal failure requiring dialysis.
- Patients with a confirmed coagulation disorder or severe coagulation system disease.
- Patients with clear contraindications to anticoagulant use.
- History of acute peptic ulcer or gastrointestinal bleeding within the past 3 months.
- Known allergy to contrast agents or nickel-titanium alloy products.
- Tricuspid valve stenosis (defined as a tricuspid valve area ≤ 1.0 cm² and/or a mean trans-tricuspid gradient ≥ 5 mmHg).
- Left ventricular ejection fraction (LVEF) ≤ 20%.
- Severe chronic obstructive pulmonary disease requiring continuous oxygen therapy.
- Life expectancy of less than 12 months.
- Pregnant or breastfeeding women, or women planning to conceive.
- Patients deemed to have poor compliance or unable to complete the study as required; or other situations in which the investigator considers the subject unsuitable for the study.
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06605313
Start Date
June 16 2022
End Date
November 24 2027
Last Update
September 20 2024
Active Locations (1)
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1
Fuwai Cardiovascular Hospital of Yunnan Province
Kunming, Yunnan, China, 650102