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Recruiting NCT04954404

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

No phase Interventional Mitral Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcatheter mitral valve repair/transcatheter mitral valve replacement.
Who it may be relevant to
Registry conditions: Mitral Valve Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Interventions

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

Primary outcome measures

  • 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 measures (12)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital Zhejiang University School of Medicine. — Hangzhou

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. PMID 39049480

Identifiers

NCT: NCT04954404 · 2021-0593

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗