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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country2,000 target enrollmentJune 2016

ConditionsSymptomatic Aortic Stenosis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Symptomatic Aortic Stenosis
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 2000
Locations: 1
Primary Endpoint: Death from any cause
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

July 2027

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Principal Investigator

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

Second Affiliated Hospital, School of Medicine, Zhejiang University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Death from any cause

Time Frame: 1 year

Secondary Outcomes

death from cardiac causes(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
bleeding events(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
transcatheter valve failure(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
stroke(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
repeated hospitalization(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years)
vascular complications(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years)
changes in ascending aorta diameter(1 year,2 years, 3 years, 4 years, 5 years，10 years)
Death from all causes(30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
device success(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
myocardial infarction(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
acute kidney injury(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
Functional Improvement from baseline per New York Heart Association functional classification(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
permanent pacemaker implantation(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)