Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
12 participants
INTERVENTIONAL
2022-06-16
2027-11-24
Brief Summary
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Detailed Description
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It plans to enroll 12 qualified patients. The primary endpoint of the study is the postoperative technical success rate. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
Subjects who received treatment with the experimental device will be included in this arm.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. NYHA classification of II, III, or IVa.
3. Age ≥ 18 years old, gender not limited.
4. 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).
5. 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.
6. Tricuspid valve coaptation defect\<2cm.
7. No significant calcification of tricuspid valve leaflets.
8. Tricuspid valve leaflet anatomy suitable for clip implantation, positioning on the leaflets and sufficient reduction in TR.
Exclusion Criteria
2. Any cardiovascular interventional procedure within the past 30 days.
3. Patients with other valvular diseases requiring surgical or interventional treatment.
4. Patients with severe large-vessel disease requiring surgical treatment.
5. Echocardiogram indicating the presence of intracardiac masses, thrombus, or vegetations.
6. Severe uncontrolled hypertension (systolic blood pressure \[SBP\] ≥ 180 mmHg and/or diastolic blood pressure \[DBP\] ≥ 110 mmHg).
7. Pulmonary artery systolic pressure \> 70 mmHg.
8. Moderate to severe or severe mitral regurgitation (≥3+).
9. Active infective endocarditis, active rheumatic heart disease, or rheumatic tricuspid valve disease.
10. Myocardial infarction or known unstable angina within the past 30 days.
11. Severe untreated coronary artery disease.
12. 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.
13. Cerebrovascular accident within the past 3 months.
14. Renal failure requiring dialysis.
15. Patients with a confirmed coagulation disorder or severe coagulation system disease.
16. Patients with clear contraindications to anticoagulant use.
17. History of acute peptic ulcer or gastrointestinal bleeding within the past 3 months.
18. Known allergy to contrast agents or nickel-titanium alloy products.
19. Tricuspid valve stenosis (defined as a tricuspid valve area ≤ 1.0 cm² and/or a mean trans-tricuspid gradient ≥ 5 mmHg).
20. Left ventricular ejection fraction (LVEF) ≤ 20%.
21. Severe chronic obstructive pulmonary disease requiring continuous oxygen therapy.
22. Life expectancy of less than 12 months.
23. Pregnant or breastfeeding women, or women planning to conceive.
24. 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.
18 Years
ALL
No
Sponsors
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Shanghai Shenqi Medical Technology Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xiangbin Pan, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Fuwai Cardiovascular Hospital of Yunnan Province
Locations
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Fuwai Cardiovascular Hospital of Yunnan Province
Kunming, Yunnan, China
Countries
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Other Identifiers
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TVRP01-001
Identifier Type: -
Identifier Source: org_study_id
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