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

NCT06605313 | Active Not Recruiting

• 1 other identifier: TVRP01-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• Technical success rate

  Defined by the following four conditions: 1\. No procedural mortality. 2. Successful delivery, implant, retrieval of the delivery system. 3. Successful devices release. 4. No need for any emergency surgery related to the device or surgical approach.

  immediately after intervention

Secondary Outcomes (4)

• Incidence of all-cause mortality

  30 days

• Incidence of major adverse events

  30 days

• Device success rate

  30 days

• Clinical success rate

  30 days

Study Arms (1)

SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System

EXPERIMENTAL

Subjects who received treatment with the experimental device will be included in this arm.

Device: SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System

Interventions

SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System DEVICE

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

SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

Fuwai Cardiovascular Hospital of Yunnan Province

Kunming, Yunnan, 650102, China

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Xiangbin Pan, MD, Ph.D

  Fuwai Cardiovascular Hospital of Yunnan Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: June 16, 2022
• Primary Completion: December 7, 2022
• Study Completion (Estimated): November 24, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)