NCT04954404 Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
| NCT ID | NCT04954404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Mitral Valve Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2022-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2021-05-01 with a primary completion date of 2022-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
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.
Contact & Investigator
Jian'an Wang, PhD, MD
STUDY CHAIR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT04954404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04954404 currently recruiting?
Yes, NCT04954404 is actively recruiting participants. Contact the research team at wja@zju.edu.cn for enrollment information.
Where is the NCT04954404 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04954404 clinical trial?
NCT04954404 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Jian'an Wang, PhD, MD at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 2,000 participants.