RecruitingPhase 4NCT02803294

Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

THE TORCH TRIAL:Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

2,000 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patients with symptomatic aortic stenosis/regurgitation
  • Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  • The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
  • Patients are technical and anatomical eligible for interventions

Exclusion Criteria4

  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
  • Subject refuses a blood transfusion.
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
  • Life expectancy is less than one year

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Interventions

PROCEDUREtranscatheter aortic valve replacement

Locations(1)

The Second Affiliated Hospital, School of Medicine at Zhejiang University

Hanzhou, Zhejiang, China

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NCT02803294


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