Evaluating transcatheter mitral valve interventions in Chinese patients with mitral valve disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and effectiveness of transcatheter mitral valve interventions, including repair and replacement, in a Chinese population diagnosed with mitral valve disease. It is a prospective, single-arm, single-center registry where eligible patients will receive treatment as determined by a local heart team. The study will gather valuable data on the use of various mitral valve interventional devices and their outcomes in this specific patient group.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Mitrassist Lifesciences Limited Co., Ltd. · Shanghai, Shanghai Municipality · NCT07097740

• Abbott Cephea registry for mitral valve disease

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• Using the CoolCryo System to treat Atrial Fibrillation during Mitral Valve Surgery

  This study is testing whether the CoolCryo system can safely help people with atrial fibrillation feel better during mitral valve surgery.

  Recruiting at 2 sites Medinice S.A. · Bydgoszcz and 1 other locations · NCT06557616

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.