- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925335
The China Mviv Registry
June 28, 2023 updated by: Yan Wang, Xiamen Cardiovascular Hospital, Xiamen University
Evaluation of Clinical Outcomes of Transseptal Transcatheter Mitral Valve-in-Valve Replacement for Degenerated Bioprostheses - The China Mviv Registry
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..
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiang Chen, Dr
- Phone Number: 18033997788
- Email: Seanchenx@126.com
Study Contact Backup
- Name: Yan Wang, dr
- Email: wy@medmail.com.cn
Study Locations
-
-
Fujian
-
Xiamen, Fujian, China, 361000
- Recruiting
- Yan Wang
-
Contact:
- Yan Wang, dr
- Email: wy@medmail.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subject had a degenerated surgical mitral bioprosthesis with at least moderate to severe mitral regurgitation or severe stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2
- Subjiect is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater.
- Subject is at least 18 years old.
- Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate.
- The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center.
- The study Subject agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone/clinic follow-up.
Exclusion Criteria:
- Subject was operable with the assessment of experienced Heart Team
- Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention ≤30 days prior to Portico ViV index procedure.
- Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC<3,000 mm3), acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <50,000 cells/mm³).
- Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)
- Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
- Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
- Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3 months prior to ViV index procedure.
- Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) ≤6 months prior to index procedure.
- Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure.
- Subject was unable to tolerate antiplatelet or anticoagulant therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcatheter mitral valve-in-valve implantation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all-cause mortality
Time Frame: 12 months
|
The rate in all-cause mortality will be calculated from 0 month to 12 months.
|
12 months
|
Rate of New hospitalization for heart failure
Time Frame: 12 months
|
Hospitalization for valve-related symptoms or worsening congestive heart failure
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical success
Time Frame: 24 hours
|
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
|
24 hours
|
Procedure success
Time Frame: 12 months
|
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
Time Frame: annual for five years
|
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
Time Frame: annual for five years
|
Hospitalization for valve-related symptoms or worsening congestive heart failure
|
annual for five years
|
Rate of myocardial infarction
Time Frame: annual for five years
|
annual for five years
|
|
Rate of neurological events
Time Frame: annual for five years
|
All stroke, transient ischemic attack (TIA)
|
annual for five years
|
Rate of Structural Valve dysfunction
Time Frame: annual for five years
|
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
Time Frame: 30 days, 6 months, 12 months, annual for five years]
|
Change in New York Heart Association (NYHA) functional classification from baseline
|
30 days, 6 months, 12 months, annual for five years]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yan Wang, Dr, Clinical Trial Center of Xiamen Cardiovascular Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 11, 2023
Primary Completion (Estimated)
July 11, 2024
Study Completion (Estimated)
June 11, 2025
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
June 28, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023YLK 21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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