NCT05770648

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Shanghai Huihe Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of the transcatheter tricuspid valve ring system produced by Shanghai Huihe Medical Technology Co., Ltd. in the treatment of patients with severe or above tricuspid regurgitation who cannot be evaluated by clinicians for surgery.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter Annuloplasty	Under the guidance of ultrasound, the transcatheter tricuspid ring forming system accurately reaches the designated position of the tricuspid valve region through the jugular vein and superior vena cava approach. The expanded tricuspid ring tissue is clammed together with the clamping parts and anchor parts, and the circumference of the tricuspid ring is reduced, thus reducing the area of the opening of the tricuspid valve that cannot be closed originally, and achieving the purpose of minimally invasive treatment of tricuspid regurgitation.
OTHER	The guidelines guide medication	The guidelines guide medication

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2023-03-15
• Last updated: 2023-03-15