Bioprosthesis FailureNCT05925335
The China Mviv Registry
A study testing Transseptal Transcatheter Mitral valve-in-valve Replacement in people with Bioprosthesis Failure and Mitral Stenosis With Insufficiency, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bioprosthesis Failure, Mitral Stenosis With Insufficiency, Mitral Stenosis
- What is being tested?
- Transseptal Transcatheter Mitral valve-in-valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2023to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Yan Wang, Dr contact
China1 site, 1 recruiting
- Recruiting
Yan Wang
Xiamen, Fujian, 361000
Yan Wang, dr, wy@medmail.com.cn
About this study
Official title: 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..
Read the 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.
- Conditions
- Bioprosthesis Failure, Mitral Stenosis With Insufficiency, Mitral Stenosis, Mitral Regurgitation, Heart Failure
- Being tested
- Transseptal Transcatheter Mitral valve-in-valve Replacement
- Medical subject headings
- Mitral Valve Stenosis, Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transseptal Transcatheter Mitral valve-in-valve ReplacementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter mitral valve-in-valve implantation | Experimental | Not described Receives: Device: Transseptal Transcatheter Mitral valve-in-valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
The rate in all-cause mortality will be calculated from 0 month to 12 months.
Measured: 12 months
Rate of New hospitalization for heart failure
Hospitalization for valve-related symptoms or worsening congestive heart failure
Measured: 12 months
Secondary outcomes (8)
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
Measured: 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.
Measured: 12 months
all-cause mortality
The rate in all-cause mortality will be calculated from 0 month to 12 months.
Measured: annual for five years
Rate of New hospitalization for heart failure
Hospitalization for valve-related symptoms or worsening congestive heart failure
Measured: annual for five years
Rate of myocardial infarction
Measured: annual for five years
Rate of neurological events
All stroke, transient ischemic attack (TIA)
Measured: 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.
Measured: annual for five years
Clinical Benefit Endpoint
Change in New York Heart Association (NYHA) functional classification from baseline
Measured: 30 days, 6 months, 12 months, annual for five years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start11 Jul 2023 (estimated)
- Primary completion11 Jul 2024 (estimated)
- Study completion11 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioprosthesis FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Wang, Xiamen Cardiovascular Hospital, Xiamen University
- Investigators
- Yan Wang, Dr, Principal investigator, Clinical Trial Center of Xiamen Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925335
- Sponsor's protocol ID
- 2023YLK 21
- Status last verified
- Jun 2023
- First submitted
- 11 May 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of Transseptal Transcatheter Mitral Valve-in-Valve Replacement for Degenerated Bioprostheses - The China Mviv Registry
- ClinicalTrials.gov ID
- NCT05925335
- Acronym / sponsor ID
- 2023YLK 21
- Conditions
- Bioprosthesis Failure, Mitral Stenosis With Insufficiency, Mitral Stenosis, Mitral Regurgitation, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen UniversityUniversity, hospital or other
- Study start
- 11 Jul 2023 (estimated)
- Primary completion
- 11 Jul 2024 (estimated)
- Study completion
- 11 Jun 2025 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter mitral valve-in-valve implantation | Experimental | Device: Transseptal Transcatheter Mitral valve-in-valve Replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transseptal Transcatheter Mitral valve-in-valve ReplacementTranscatheter 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. | Device | Transcatheter mitral valve-in-valve implantation |
Primary outcome
all-cause mortality
Time frame: 12 months
The rate in all-cause mortality will be calculated from 0 month to 12 months.
Rate of New hospitalization for heart failure
Time frame: 12 months
Hospitalization for valve-related symptoms or worsening congestive heart failure
8 secondary outcomes
Technical success
Time frame: 24 hours
Procedure success
Time frame: 12 months
all-cause mortality
Time frame: annual for five years
Rate of New hospitalization for heart failure
Time frame: annual for five years
Rate of myocardial infarction
Time frame: annual for five years
Rate of neurological events
Time frame: annual for five years
Rate of Structural Valve dysfunction
Time frame: annual for five years
Clinical Benefit Endpoint
Time frame: 30 days, 6 months, 12 months, annual for five years]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wang, Dr contact
Yan Wang, Dr principal investigator
Clinical Trial Center of Xiamen Cardiovascular Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transseptal Transcatheter Mitral valve-in-valve Replacement in people with Bioprosthesis Failure and Mitral Stenosis With Insufficiency, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Chen, Dr (18033997788, Seanchenx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.