Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Phase 4RecruitingNCT02803294

Second Affiliated Hospital, School of Medicine, Zhejiang University2,000 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Symptomatic Aortic Stenosis

Interventions

transcatheter aortic valve replacementPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Second Affiliated Hospital, School of Medicine at Zhejiang University

Hanzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Death from any cause

Time frame: 1 year