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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-clipTM transcatheter annuloplasty system+Guideline Directed Medical Therapy GDMT | Experimental |
| |
| Guideline Directed Medical Therapy, GDMT | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Annuloplasty | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects with no all-cause death, no heart failure readmitted, NYHA increased by one grade or more, and TR decreased ≥1+ within 6 months after randomization. | The percentage of subjects with no all-cause death, no heart failure readmitted, NYHA increased by one grade or more, and TR decreased ≥1+ within 6 months after randomization. | Within 6 months of randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| The guidelines guide medication | Other | The guidelines guide medication |
|
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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