Mitral Valve DiseaseNCT04954404
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
A study testing transcatheter mitral valve repair/transcatheter mitral valve replacement in people with Mitral Valve Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- transcatheter mitral valve repair/transcatheter mitral valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
- Patients are technical and anatomical eligible for interventions.
Who cannot join
- In the judgment of the investigator, subjects are not anatomical eligible for interventions.
- Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
- Active endocarditis or active rheumatic heart disease.
- History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
- Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.
- Subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine.
Hangzhou, Zhejiang, 310006
Jian'an Wang, MD, wja@zju.edu.cn
About this study
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
Read the detailed description
Prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. Eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement.
This single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
- Conditions
- Mitral Valve Disease
- Being tested
- transcatheter mitral valve repair/transcatheter mitral valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter mitral valve repair/transcatheter mitral valve replacementDevice
transcatheter mitral valve repair/transcatheter mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter mitral valve repair/replacement | Experimental | Not described Receives: Device: transcatheter mitral valve repair/transcatheter mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary outcomes (36)
All-cause mortality
Death from any causes including both cardiovascular and non-cardiovascular.
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Cardiovascular mortality
Death from any cardiovascular events.
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Rehospitalization related to heart failure
Number of patients readmission for recurrent Heart Failure.
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Stroke
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Transient ischemic attack
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Brain lesion
Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom.
Measured: Predischarge
Myocardial infarction
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Vascular complications
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Bleeding events
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Permanent pacemaker implantation
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Device success
Defined according to consensus document from the mitral valve academic research consortium (MVARC).
Measured: Immediately after procedure
Infective endocarditis
Number of patients with infective endocarditis.
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Recurrent hospitalization - All cause
Number of patients hospitalized for≥24h. Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition according to MVARC.
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Acute kidney injury
Measured: Predischarge, 30 days
New-onset atrial fibrillation
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Change of New York Heart Association functional classification
Change of NYHA status from baseline to each follow-up.
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
MR and/or MS severity
The change in MR and/or MS severity from baseline to each follow-up.
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Quality of life improvement
Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Modified Rankin scale score
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Change of cognitive function
Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination （MMSE）.
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
6-min walk test
The change in 6-min walk test distance from baseline to each follow-up.
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Reintervention of mitral valve
Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration.
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Significant iatrogenic atrial septal defect
Number of patients reported as clinically significant iASD requiring ASD closure.
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Device embolization or single leaflet device attachment
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Effective regurgitant orifice area
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Regurgitant volume
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Regurgitant fraction
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Mitral valve area
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Mean mitral valve gradient
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular ejection fraction (LVEF)
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular end-diastolic diameter (LVEDD)
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular end-systolic diameter (LVESD)
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Pulmonary artery systolic pressure (PASP)
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Right ventricular systolic pressure (RVSP)
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular mass
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
BNP and/or NT-proBNP levels
Measured: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Model description
- Transcatheter mitral valve repair/Transcatheter mitral valve replacement
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian'an Wang, PhD, MD, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954404
- Sponsor's protocol ID
- 2021-0593
- Status last verified
- May 2021
- First submitted
- 20 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pu Z, Yu T, Liu X, Lin X, Li H, Lim DS, Wang J. A modified Carpentier classification in transcatheter edge-to-edge repair for mitral regurgitation. Catheter Cardiovasc Interv. 2024 Oct;104(4):870-877. doi: 10.1002/ccd.31158. Epub 2024 Jul 24.
PubMed 39049480
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
- ClinicalTrials.gov ID
- NCT04954404
- Acronym / sponsor ID
- 2021-0593
- Conditions
- Mitral Valve Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 8 Jul 2021 (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.
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
Detailed description
Prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. Eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement.
This single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Transcatheter mitral valve repair/Transcatheter mitral valve replacement
| Arm | Type | Receives |
|---|---|---|
| Transcatheter mitral valve repair/replacement | Experimental | Device: transcatheter mitral valve repair/transcatheter mitral valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
- Patients are technical and anatomical eligible for interventions.
Key exclusion criteria (6 listed)
- In the judgment of the investigator, subjects are not anatomical eligible for interventions.
- Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
- Active endocarditis or active rheumatic heart disease.
- History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
- Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.
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 |
|---|---|---|
| transcatheter mitral valve repair/transcatheter mitral valve replacementtranscatheter mitral valve repair/transcatheter mitral valve replacement | Device | Transcatheter mitral valve repair/replacement |
Primary outcome
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
36 secondary outcomes
All-cause mortality
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Cardiovascular mortality
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Rehospitalization related to heart failure
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Stroke
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Transient ischemic attack
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Brain lesion
Time frame: Predischarge
Myocardial infarction
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Vascular complications
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Bleeding events
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Permanent pacemaker implantation
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Device success
Time frame: Immediately after procedure
Infective endocarditis
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Recurrent hospitalization - All cause
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Acute kidney injury
Time frame: Predischarge, 30 days
New-onset atrial fibrillation
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Change of New York Heart Association functional classification
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
MR and/or MS severity
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Quality of life improvement
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Modified Rankin scale score
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Change of cognitive function
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
6-min walk test
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Reintervention of mitral valve
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Significant iatrogenic atrial septal defect
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Device embolization or single leaflet device attachment
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Effective regurgitant orifice area
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Regurgitant volume
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Regurgitant fraction
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Mitral valve area
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Mean mitral valve gradient
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular ejection fraction (LVEF)
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular end-diastolic diameter (LVEDD)
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular end-systolic diameter (LVESD)
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Pulmonary artery systolic pressure (PASP)
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Right ventricular systolic pressure (RVSP)
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular mass
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
BNP and/or NT-proBNP levels
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 39049480Pu Z, Yu T, Liu X, Lin X, Li H, Lim DS, Wang J. A modified Carpentier classification in transcatheter edge-to-edge repair for mitral regurgitation. Catheter Cardiovasc Interv. 2024 Oct;104(4):870-877. doi: 10.1002/ccd.31158. Epub 2024 Jul 24.
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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.
Jian'an Wang, PhD, MD study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter mitral valve repair/transcatheter mitral valve replacement in people with Mitral Valve Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Jul 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian'an Wang, PhD, MD (+86057187783777, wja@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure. (time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954404, which also lists 1 linked publication.
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 8 Jul 2021.