RecruitingNCT06381271

Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation

Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)


Sponsor

Xijing Hospital

Enrollment

500 participants

Start Date

Oct 30, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • \. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
  • \. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form

Exclusion Criteria3

  • \. Patients who cannot provide informed consent
  • \. Patients who are treated with TAVR for aortic stenosis
  • \. Patients who are participating in other clinical trials

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Interventions

PROCEDURETranscatheter aortic valve replacement

A total of 500 consecutive patients with NAVR undergoing TAVR will be enrolled at 3-5 centers. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years


Locations(1)

Xijing Hospital

Xi'an, Shannxi, China

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NCT06381271


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