Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Overview

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

Full Title of Study: “THE TORCH TRIAL:Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2026

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.

Interventions

  • Procedure: transcatheter aortic valve replacement

Arms, Groups and Cohorts

  • Experimental: Aortic Stenosis/regurgitation
    • Transcatheter aortic valve replacement

Clinical Trial Outcome Measures

Primary Measures

  • Death from any cause
    • Time Frame: 1 year

Secondary Measures

  • stroke
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
  • death from cardiac causes
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
  • myocardial infarction
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
  • repeated hospitalization
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years, 10 years
  • acute kidney injury
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
  • vascular complications
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
  • bleeding events
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
  • device success
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
    • Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
  • Functional Improvement from baseline per New York Heart Association functional classification
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
  • permanent pacemaker implantation
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
    • number of patients who develop permanent third-degree or type 2(Mobitz) Secondary atrioventricular block after transcatheter aortic valve replacement and need permanent pacemaker implantation.
  • transcatheter valve failure
    • Time Frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
    • leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve
  • changes in ascending aorta diameter
    • Time Frame: 1 year,2 years, 3 years, 4 years, 5 years,10 years
  • Death from all causes
    • Time Frame: 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years,10 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • 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
  • Overall Official(s)
    • Jian-an Wang, MD,PhD, Principal Investigator, Second Affiliated Hospital of Zhejiang University School of Medicine
  • Overall Contact(s)
    • Xianbao Liu, MD, +86-13857173887, liuxb2009@hotmail.com

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