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

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

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Disease
• Intervention / Treatment: Device: transcatheter mitral valve repair/transcatheter mitral valve replacement

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian'an Wang, PhD, MD; Phone Number: +86057187783777; Email: wja@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter mitral valve repair/replacement	Device: transcatheter mitral valve repair/transcatheter mitral valve replacement; transcatheter mitral valve repair/transcatheter mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cardiovascular mortality	Death from any cardiovascular events.	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.	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Stroke		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Transient ischemic attack		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.	Predischarge
Myocardial infarction		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Vascular complications		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Bleeding events		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Permanent pacemaker implantation		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).	Immediately after procedure
Infective endocarditis	Number of patients with infective endocarditis.	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.	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Acute kidney injury		Predischarge, 30 days
New-onset atrial fibrillation		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.	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.	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).	30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Modified Rankin scale score		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）.	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.	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.	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.	Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Device embolization or single leaflet device attachment		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Effective regurgitant orifice area		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Regurgitant volume		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Regurgitant fraction		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Mitral valve area		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Mean mitral valve gradient		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular ejection fraction (LVEF)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular end-diastolic diameter (LVEDD)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular end-systolic diameter (LVESD)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Pulmonary artery systolic pressure (PASP)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Right ventricular systolic pressure (RVSP)		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Left ventricular mass		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
BNP and/or NT-proBNP levels		Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Jian'an Wang, PhD, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2031

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2021-0593

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No