NCT06257043 Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients
| NCT ID | NCT06257043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Aortic Valve Disease Mixed |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2033-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-10-30 with a primary completion date of 2033-11-01.
⚠ 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 prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.
Eligibility Criteria
Inclusion Criteria: 1. Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy 2. Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form Exclusion Criteria: 1. Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR 2. Patients who cannot tolerate the materials or medications associated with this study 3. Women who are pregnant or breastfeeding 4. Patients who participated in a clinical trial of another drug or medical device before enrollment
Contact & Investigator
Ling Tao, M.D, Ph.D
STUDY CHAIR
Xijing Hospital
Frequently Asked Questions
Who can join the NCT06257043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Disease Mixed. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06257043 currently recruiting?
Yes, NCT06257043 is actively recruiting participants. Contact the research team at rutaowang@qq.com for enrollment information.
Where is the NCT06257043 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06257043 clinical trial?
NCT06257043 is sponsored by Xijing Hospital. The principal investigator is Ling Tao, M.D, Ph.D at Xijing Hospital. The trial plans to enroll 3,000 participants.