Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients
RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
Xijing Hospital
3,000 participants
Oct 30, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria2
- Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy
- Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form
Exclusion Criteria4
- Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR
- Patients who cannot tolerate the materials or medications associated with this study
- Women who are pregnant or breastfeeding
- Patients who participated in a clinical trial of another drug or medical device before enrollment
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Interventions
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
Locations(1)
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NCT06257043