Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2027-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Symptomatic Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aortic Stenosis/regurgitation

Transcatheter aortic valve replacement

Group Type EXPERIMENTAL

transcatheter aortic valve replacement

Intervention Type PROCEDURE

Interventions

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transcatheter aortic valve replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jian'an Wang,MD,PhD

President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsibility Role PRINCIPAL_INVESTIGATOR