Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)

Mitral Valve Disease Clinical Trial

Official title:

Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954404
• Other study ID #: 2021-0593
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2031

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jian'an Wang, PhD, MD
• Phone: +86057187783777
• Email: wja[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 1, 2031
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.

4. Patients are technical and anatomical eligible for interventions.

Exclusion Criteria:

1. In the judgment of the investigator, subjects are not anatomical eligible for interventions.

2. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.

3. Active endocarditis or active rheumatic heart disease.

4. History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.

5. 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.

6. 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.

Related Conditions & MeSH terms

• Heart Valve Diseases
• Mitral Valve Disease

Intervention

Device:
• transcatheter mitral valve repair/transcatheter mitral valve replacement
transcatheter mitral valve repair/transcatheter mitral valve replacement

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine.	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	All-cause mortality	Death from any causes including both cardiovascular and non-cardiovascular.	Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Cardiovascular mortality	Death from any cardiovascular events.	Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Rehospitalization related to heart failure	Number of patients readmission for recurrent Heart Failure.	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Stroke		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Transient ischemic attack		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Brain lesion	Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom.	Predischarge
Secondary	Myocardial infarction		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Vascular complications		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Bleeding events		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Permanent pacemaker implantation		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Device success	Defined according to consensus document from the mitral valve academic research consortium (MVARC).	Immediately after procedure
Secondary	Infective endocarditis	Number of patients with infective endocarditis.	Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	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.	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Acute kidney injury		Predischarge, 30 days
Secondary	New-onset atrial fibrillation		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Change of New York Heart Association functional classification	Change of NYHA status from baseline to each follow-up.	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	MR and/or MS severity	The change in MR and/or MS severity from baseline to each follow-up.	Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Quality of life improvement	Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Modified Rankin scale score		30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Change of cognitive function	Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination (MMSE).	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	6-min walk test	The change in 6-min walk test distance from baseline to each follow-up.	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Reintervention of mitral valve	Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration.	Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Significant iatrogenic atrial septal defect	Number of patients reported as clinically significant iASD requiring ASD closure.	Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Device embolization or single leaflet device attachment		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Effective regurgitant orifice area		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Regurgitant volume		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Regurgitant fraction		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Mitral valve area		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Mean mitral valve gradient		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Left ventricular ejection fraction (LVEF)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Left ventricular end-diastolic diameter (LVEDD)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Left ventricular end-systolic diameter (LVESD)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Pulmonary artery systolic pressure (PASP)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Right ventricular systolic pressure (RVSP)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	Left ventricular mass		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Secondary	BNP and/or NT-proBNP levels		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years