Transcatheter aortic valve replacement for patients in China
THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
This study tests whether a heart valve replacement procedure called TAVR is safe and effective for people in China with serious heart valve problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| 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 (Hanzhou, Zhejiang) |
| Trial ID | NCT02803294 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of transcatheter aortic valve replacement (TAVR) specifically in the Chinese population suffering from symptomatic aortic stenosis or severe aortic regurgitation. Patients undergo thorough physical exams and screening tests to determine their eligibility for the procedure. Those who qualify will receive TAVR and will be monitored for outcomes related to the intervention. The study aims to gather data that could inform future treatment protocols for this demographic.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with symptomatic aortic stenosis or severe aortic regurgitation who meet specific technical and anatomical criteria for the procedure.
Not a fit: Patients with a life expectancy of less than one year or those with contraindications to the procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with symptomatic aortic stenosis in the Chinese population.
How similar studies have performed: Other studies have shown success with transcatheter aortic valve replacement, but this specific focus on the Chinese population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with symptomatic aortic stenosis/regurgitation * 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: * A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media * Subject refuses a blood transfusion. * Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. * Life expectancy is less than one year
Where this trial is running
Hanzhou, Zhejiang
- The Second Affiliated Hospital, School of Medicine at Zhejiang University — Hanzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jian-an Wang, MD,PhD — Second Affiliated Hospital of Zhejiang University School of Medicine
- Study coordinator: Xianbao Liu, MD
- Email: liuxb2009@hotmail.com
- Phone: +86-13857173887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.