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The present clinical trial is performed to evaluate the effectiveness and safety of transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Healthcare technology Co.,Ltd. for the treatment of subjects with severe or worse tricuspid regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-clipTM transcatheter annuloplasty system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Annuloplasty | Device | Under echocardiography guidance, the transcatheter tricuspid annuloplasty system precisely reaches the specified position in the tricuspid valve region via jugular vein and superior vena cava approach. The enlarged tricuspid annular tissue is clamped with the clamp cpart and anchor part to reduce the perimeter of tricuspid annulus, so that the area of tricuspid orifice that could not be coapted is reduced. It plays the purpose of minimally invasive treatment of tricuspid valve. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 1-year after operation | |
| Change of Tricuspid Regurgitation Grade | Change of Tricuspid Regurgitation Grade assessed by corelab than baseline | 1-year after operation |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of post operation 12 months | 2 years, 3years, 4 years, 5 years | |
| Success rate of device implantation | intra-procedure | |
| Change in echocardiographic parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39663060 | Derived | Xu H, Chen M, Wang Z, Huo J, Li J, He F, Husanova F, Li H, Zhou D, Zhang X, Liu X, Song G, Li J, Luo J, Guo Y, Mou Y, Yuan S, Tao T, Wu S, Teng P, Ni Y, Ma L, Pan X, Ge J, Lee AP, Li W. Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation. JACC Cardiovasc Interv. 2024 Dec 9;17(23):2796-2807. doi: 10.1016/j.jcin.2024.10.007. | |
| 38938712 |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
Change in echocardiographic parameters:Tricuspid annulus A-P diameter(mm)、 Tricuspid annulus perimeter(mm)、Tricuspid annulus area(cm2)、Vena contracta width(mm)、EROA(cm2)、Regurgitation volume(ml)、IVC(mm)。 |
| 1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years |
| Change of Tricuspid Regurgitation Grade | 1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years |
| NYHA | 1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years |
| 6 minutes walk distance | 1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years |
| Derived |
| Xu H, Li W, Lee AP, Wu S, Husanova F, Wu B, Mou Y, Gu Y, Chen M, Tao T, Zhang Y, Zheng J, Yang A, Yuan S, Wang Q, Ni Y, Ma L. 30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System: A Single-Center, Observational Study. JACC Adv. 2023 Oct 27;2(9):100671. doi: 10.1016/j.jacadv.2023.100671. eCollection 2023 Nov. |
| 36517335 | Derived | Wollborn J, Schuler A, Sheu RD, Shook DC, Nyman CB. Real-Time Multiplanar Reconstruction Imaging Using 3-Dimensional Transesophageal Echocardiography in Structural Heart Interventions. J Cardiothorac Vasc Anesth. 2023 Apr;37(4):570-581. doi: 10.1053/j.jvca.2022.11.011. Epub 2022 Nov 13. |