Back to resultsTranscatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
Primary Purpose
Mitral Valve Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcatheter mitral valve repair/transcatheter mitral valve replacement
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The Second Affiliated Hospital Zhejiang University School of Medicine.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcatheter mitral valve repair/replacement
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
All-cause mortality
Death from any causes including both cardiovascular and non-cardiovascular.
Cardiovascular mortality
Death from any cardiovascular events.
Rehospitalization related to heart failure
Number of patients readmission for recurrent Heart Failure.
Stroke
Transient ischemic attack
Brain lesion
Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom.
Myocardial infarction
Vascular complications
Bleeding events
Permanent pacemaker implantation
Device success
Defined according to consensus document from the mitral valve academic research consortium (MVARC).
Infective endocarditis
Number of patients with infective endocarditis.
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.
Acute kidney injury
New-onset atrial fibrillation
Change of New York Heart Association functional classification
Change of NYHA status from baseline to each follow-up.
MR and/or MS severity
The change in MR and/or MS severity from baseline to each follow-up.
Quality of life improvement
Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Modified Rankin scale score
Change of cognitive function
Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination （MMSE）.
6-min walk test
The change in 6-min walk test distance from baseline to each follow-up.
Reintervention of mitral valve
Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration.
Significant iatrogenic atrial septal defect
Number of patients reported as clinically significant iASD requiring ASD closure.
Device embolization or single leaflet device attachment
Effective regurgitant orifice area
Regurgitant volume
Regurgitant fraction
Mitral valve area
Mean mitral valve gradient
Left ventricular ejection fraction (LVEF)
Left ventricular end-diastolic diameter (LVEDD)
Left ventricular end-systolic diameter (LVESD)
Pulmonary artery systolic pressure (PASP)
Right ventricular systolic pressure (RVSP)
Left ventricular mass
BNP and/or NT-proBNP levels
Full Information
NCT ID
NCT04954404
First Posted
June 20, 2021
Last Updated
June 29, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04954404
Brief Title
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
Official Title
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Transcatheter mitral valve repair/Transcatheter mitral valve replacement
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcatheter mitral valve repair/replacement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
transcatheter mitral valve repair/transcatheter mitral valve replacement
Intervention Description
transcatheter mitral valve repair/transcatheter mitral valve replacement
Primary Outcome Measure Information:
Title
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Description
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
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Death from any causes including both cardiovascular and non-cardiovascular.
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Cardiovascular mortality
Description
Death from any cardiovascular events.
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Rehospitalization related to heart failure
Description
Number of patients readmission for recurrent Heart Failure.
Time Frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Stroke
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Transient ischemic attack
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Brain lesion
Description
Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom.
Time Frame
Predischarge
Title
Myocardial infarction
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Vascular complications
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Bleeding events
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Permanent pacemaker implantation
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Device success
Description
Defined according to consensus document from the mitral valve academic research consortium (MVARC).
Time Frame
Immediately after procedure
Title
Infective endocarditis
Description
Number of patients with infective endocarditis.
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Recurrent hospitalization - All cause
Description
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.
Time Frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Acute kidney injury
Time Frame
Predischarge, 30 days
Title
New-onset atrial fibrillation
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Change of New York Heart Association functional classification
Description
Change of NYHA status from baseline to each follow-up.
Time Frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
MR and/or MS severity
Description
The change in MR and/or MS severity from baseline to each follow-up.
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Quality of life improvement
Description
Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time Frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Modified Rankin scale score
Time Frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Change of cognitive function
Description
Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination （MMSE）.
Time Frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
6-min walk test
Description
The change in 6-min walk test distance from baseline to each follow-up.
Time Frame
30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Reintervention of mitral valve
Description
Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration.
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Significant iatrogenic atrial septal defect
Description
Number of patients reported as clinically significant iASD requiring ASD closure.
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Device embolization or single leaflet device attachment
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Effective regurgitant orifice area
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Regurgitant volume
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Regurgitant fraction
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Mitral valve area
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Mean mitral valve gradient
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Left ventricular ejection fraction (LVEF)
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Left ventricular end-diastolic diameter (LVEDD)
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Left ventricular end-systolic diameter (LVESD)
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Pulmonary artery systolic pressure (PASP)
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Right ventricular systolic pressure (RVSP)
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
Left ventricular mass
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Title
BNP and/or NT-proBNP levels
Time Frame
Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian'an Wang, PhD, MD
Phone
+86057187783777
Email
wja@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian'an Wang, PhD, MD
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian'an Wang, MD
Email
wja@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
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