Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:17 AM
Study NCT ID:
NCT07433504
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.
Sponsor:
Shanghai Huihe Medical Technology Co., Ltd
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Tricuspid Valve Clipping Systems in Patients With Severe or Greater Tricuspid Regurgitation.
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The transcatheter tricuspid valve clipping system is specially designed for the treatment of tricuspid regurgitation. Under the guidance of ultrasound and DSA imaging, the investigational device is advanced into the right ventricle via a femoral or jugular venous puncture approach. The clipping component grasps the edges of the dysfunctional valve leaflets (usually unable to close properly), thereby reducing the area of the tricuspid orifice that fails to coapt normally, achieving minimally invasive treatment of tricuspid regurgitation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: