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Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease. There are 2 types of valve often been used, mechanical or biological protheses valves. Mechanical valve requires lifelong use of anticoagulants and take the risk of bleeding through all lifetime, but bioprotheses valve do not..
Due to a massive shift from mechanical to bioprosthetic valves with finite longevity, increasing numbers of patients are presenting with bioprosthetic mitral valve degeneration. Mitral valve reoperation, the standard therapy for the bioprosthetic failure in the past, often entails high risk due to age, multiple comorbidities et al. TMVR is an emerging treatment for the patients with bioprosthetic failure at high risk for conventional mitral valve surgery. Recent studies from US and Europe have demonstrated the safety and efficacy of TMVR in this population. However, there are limited data regarding clinical outcomes after TMVR from Asia-Pacific region. To evaluate the safety and efficacy of TMVR using balloon-expandable valve among those patients with high risk for redo surgery and those who refuse redo surgery after shared decision making even they have less than high risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter mitral valve-in-valve implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transseptal Transcatheter Mitral valve-in-valve Replacement | Device | Transcatheter transfemoral mitral valve-in-valve replacement is an alternative surgery in patients with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The procedure is performed via femoral vein access. All procedures were carried out using intra-procedural TEE guidance to aid in transseptal puncture. After balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle and expanded in the mitral position during rapid ventricle pacing. |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | The rate in all-cause mortality will be calculated from 0 month to 12 months. | 12 months |
| Rate of New hospitalization for heart failure | Hospitalization for valve-related symptoms or worsening congestive heart failure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success was the primary safety endpoint at the time of patient exit from the cardiac catheterization laboratory, which was defined as the delivery and retrieval of the transcatheter delivery system being successful, the deployment of a single valve in the proper position in the mitral annulus, no need for surgery or additional reintervention, and the patient leaving the procedure room alive |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Chen, Dr | Contact | 18033997788 | Seanchenx@126.com | |
| Yan Wang, Dr | Contact | wy@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yan Wang, Dr | Clinical Trial Center of Xiamen Cardiovascular Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yan Wang | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D008946 | Mitral Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 24 hours |
| Procedure success | Procedure success defiened as adequate performance of the THV with residual MR grade < 2 and mean MV gradient (MVG) < 10 mm Hg. | 12 months |
| all-cause mortality | The rate in all-cause mortality will be calculated from 0 month to 12 months. | annual for five years |
| Rate of New hospitalization for heart failure | Hospitalization for valve-related symptoms or worsening congestive heart failure | annual for five years |
| Rate of myocardial infarction | annual for five years |
| Rate of neurological events | All stroke, transient ischemic attack (TIA) | annual for five years |
| Rate of Structural Valve dysfunction | as assessed by transthoracic echocardiography with residual MR grade > 2 and mean MV gradient (MVG) ≥ 10 mm Hg. | annual for five years |
| Clinical Benefit Endpoint | Change in New York Heart Association (NYHA) functional classification from baseline | 30 days, 6 months, 12 months, annual for five years] |