Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population (TORCH)

Zhejiang University

Status and phase

Enrolling

Phase 4

Conditions

Symptomatic Aortic Stenosis

Treatments

Procedure: transcatheter aortic valve replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT02803294

SAHZJU CT006

Details and patient eligibility

About

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

Full description

Subjects enrolled are those who undergo physical exams and screening tests and were classified as a patient with symptomatic aortic stenosis or severe aortic regurgitation. They are then performed transcatheter aortic valve replacement.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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