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

Second Affiliated Hospital, School of Medicine, Zhejiang University2,000 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Mitral Valve Disease

Interventions

transcatheter mitral valve repair/transcatheter mitral valve replacementDEVICE

transcatheter mitral valve repair/transcatheter mitral valve replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine.

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

All-cause mortality

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

Cardiovascular mortality

Death from any cardiovascular events.

Time frame: 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.

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

Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom.

Time frame: Predischarge

Myocardial infarction

Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

Central Contacts

Jian'an Wang, PhD, MD

CONTACT

+86057187783777 wja@zju.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Defined according to consensus document from the mitral valve academic research consortium (MVARC).

Time frame: Immediately after procedure

Infective endocarditis

Number of patients with infective endocarditis.

Time frame: 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.

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

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

MR and/or MS severity

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

Quality of life improvement

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

Modified Rankin scale score

Time frame: 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）.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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