Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

• Aged 60 or older, regardless of gender;

• Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);

• The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. \[No. of experts in cardiovascular surgery \>=2\]) considers the subjects to be at high risk for surgical operation (STS score \> 6.0%) and expects that they will benefit from the transcatheter tricuspid annulus repair;

• Patient with normal left ventricular function (LVEF≥40%);

• The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.

Locations
Other Locations
China
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
RECRUITING
Shanghai
Contact Information
Primary
Sally Yan, project supervisor
Sally.yan@hh-healthcare.com
18800263183
Time Frame
Start Date: 2021-09-16
Estimated Completion Date: 2026-09-16
Participants
Target number of participants: 10
Treatments
Experimental: K-clipTM transcatheter annuloplasty system
Related Therapeutic Areas
Sponsors
Leads: Shanghai Huihe Medical Technology Co., Ltd

This content was sourced from clinicaltrials.gov