Clinical trial NCT06605313: SQ-Kyrin-T First-in-man Feasibility Study
Official title: First-in-man Feasibility Study of SQ-Kyrin-T Transcatheter Tricuspid Valve Clip Delivery System and Steerable Guide Catheter in Patients With Severe Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Shanghai Shenqi Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery.

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.

Eligibility criteria: Inclusion Criteria:

1. Severe or greater (≥3+) tricuspid regurgitation determined by transthoracic echocardiogram despite adequate treatment per applicable standards.
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:

1. Previous tricuspid valve surgery; previous heart transplant; implanted cardiac electronic device.
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.

Primary outcomes:
measure: Technical success rate
timeFrame: immediately after intervention
Secondary outcomes:
measure: Incidence of all-cause mortality
timeFrame: 30 days
measure: Incidence of major adverse events
timeFrame: 30 days
measure: Device success rate
timeFrame: 30 days
measure: Clinical success rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Kunming
country: China
facility: Fuwai Cardiovascular Hospital of Yunnan Province
state: Yunnan
Study officials:
affiliation: Fuwai Cardiovascular Hospital of Yunnan Province
name: Xiangbin Pan, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: