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

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

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

Study Overview

• Status: Recruiting
• Conditions: Symptomatic Aortic Stenosis
• Intervention / Treatment: Procedure: transcatheter aortic valve replacement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital, School of Medicine at Zhejiang University
      • Contact: Xianbao Liu, PHD; Email: liuxb@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aortic Stenosis/regurgitation; Transcatheter aortic valve replacement	Procedure: transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death from any cause	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke		30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
death from cardiac causes		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
repeated hospitalization		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
vascular complications		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
device success	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)	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	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.	30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
transcatheter valve failure	leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jian-an Wang, MD,PhD, Second Affiliated Hospital of Zhejiang University School of Medicine

Publications and helpful links

General Publications

• Hu P, Chen H, Wang LH, Jiang JB, Li JM, Tang MY, Guo YC, Zhu QF, Pu ZX, Lin XP, Ng S, Liu XB, Wang JA. Elevated N-terminal pro C-type natriuretic peptide is associated with mortality in patients undergoing transcatheter aortic valve replacement. BMC Cardiovasc Disord. 2022 Apr 12;22(1):164. doi: 10.1186/s12872-022-02615-8.
• Fan J, Fang X, Liu C, Zhu G, Hou CR, Jiang J, Lin X, Wang L, He Y, Zhu Q, Ng S, Chen Z, Hu H, Liu X, Wang J, Leon MB. Brain Injury After Transcatheter Replacement of Bicuspid Versus Tricuspid Aortic Valves. J Am Coll Cardiol. 2020 Dec 1;76(22):2579-2590. doi: 10.1016/j.jacc.2020.09.605.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: SAHZJU CT006