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NCT Number: NCT04954404

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine.

Hangzhou, Zhejiang, 310006, China

Location status: Recruiting

Location contact

Jian'an Wang, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcatheter mitral valve repair/transcatheter mitral valve replacement

Device

transcatheter mitral valve repair/transcatheter mitral valve replacement

Primary outcomes

  1. 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

    Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.

Secondary outcomes

  1. All-cause mortality

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

    Death from any causes including both cardiovascular and non-cardiovascular.

  2. Cardiovascular mortality

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

    Death from any cardiovascular events.

  3. Rehospitalization related to heart failure

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

    Number of patients readmission for recurrent Heart Failure.

  4. Stroke

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

  5. Transient ischemic attack

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

  6. Brain lesion

    Time frame: Predischarge

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

  7. Myocardial infarction

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

  8. Vascular complications

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

  9. Bleeding events

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

  10. Permanent pacemaker implantation

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

  11. Device success

    Time frame: Immediately after procedure

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

  12. Infective endocarditis

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

    Number of patients with infective endocarditis.

  13. Recurrent hospitalization - All cause

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

    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.

  14. Acute kidney injury

    Time frame: Predischarge, 30 days

  15. New-onset atrial fibrillation

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

  16. Change of New York Heart Association functional classification

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

    Change of NYHA status from baseline to each follow-up.

  17. MR and/or MS severity

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

    The change in MR and/or MS severity from baseline to each follow-up.

  18. Quality of life improvement

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

    Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).

  19. Modified Rankin scale score

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

  20. Change of cognitive function

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

    Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination (MMSE).

  21. 6-min walk test

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

    The change in 6-min walk test distance from baseline to each follow-up.

  22. Reintervention of mitral valve

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

    Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration.

  23. Significant iatrogenic atrial septal defect

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

    Number of patients reported as clinically significant iASD requiring ASD closure.

  24. Device embolization or single leaflet device attachment

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

  25. Effective regurgitant orifice area

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

  26. Regurgitant volume

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

  27. Regurgitant fraction

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

  28. Mitral valve area

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

  29. Mean mitral valve gradient

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

  30. Left ventricular ejection fraction (LVEF)

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

  31. Left ventricular end-diastolic diameter (LVEDD)

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

  32. Left ventricular end-systolic diameter (LVESD)

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

  33. Pulmonary artery systolic pressure (PASP)

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

  34. Right ventricular systolic pressure (RVSP)

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

  35. Left ventricular mass

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

  36. BNP and/or NT-proBNP levels

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jian'an Wang, PhD, MD

CONTACT

[email protected]

+86057187783777

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2031
First posted
Jul 8, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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