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Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients

RECRUITINGSponsored by Xijing Hospital
Actively Recruiting
SponsorXijing Hospital
Started2023-10-30
Est. completion2033-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Aortic Valve Disease MixedHeart Disease

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