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

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

This study is testing how safe and effective new procedures for fixing or replacing the mitral valve are for Chinese patients with mitral valve disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04954404 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with mitral valve disease who are deemed suitable for intervention by a heart team.

Not a fit: Patients with anatomical ineligibility for the interventions or those with active endocarditis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with mitral valve disease.

How similar studies have performed: Other studies have shown promise with transcatheter mitral valve interventions, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Jian'an Wang, PhD, MD

Conditions Mitral Valve Disease