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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter aortic valve replacement: A total of 3000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled at 30-50 centers. The devices used will be all post-market transcatheter aortic valves approved for use in China. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years

Study 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

Primary outcome measure(s)

• Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3) — 1 year
  Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction

Trial sites (1)

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