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

Primary Purpose

Symptomatic Aortic Stenosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
transcatheter aortic valve replacement
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Aortic Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital, School of Medicine at Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aortic Stenosis/regurgitation

Arm Description

Transcatheter aortic valve replacement

Outcomes

Primary Outcome Measures

Death from any cause

Secondary Outcome Measures

stroke
death from cardiac causes
myocardial infarction
repeated hospitalization
acute kidney injury
vascular complications
bleeding events
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)
Functional Improvement from baseline per New York Heart Association functional classification
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.
transcatheter valve failure
leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve
changes in ascending aorta diameter
Death from all causes

Full Information

First Posted
June 7, 2016
Last Updated
July 14, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02803294
Brief Title
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
Acronym
TORCH
Official Title
THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Aortic Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aortic Stenosis/regurgitation
Arm Type
Experimental
Arm Description
Transcatheter aortic valve replacement
Intervention Type
Procedure
Intervention Name(s)
transcatheter aortic valve replacement
Primary Outcome Measure Information:
Title
Death from any cause
Time Frame
1 year
Secondary Outcome Measure Information:
Title
stroke
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
death from cardiac causes
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
myocardial infarction
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
repeated hospitalization
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years
Title
acute kidney injury
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
vascular complications
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
Title
bleeding events
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
device success
Description
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)
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
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
Title
permanent pacemaker implantation
Description
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.
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
transcatheter valve failure
Description
leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve
Time Frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
changes in ascending aorta diameter
Time Frame
1 year,2 years, 3 years, 4 years, 5 years，10 years
Title
Death from all causes
Time Frame
30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years，10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianbao Liu, MD
Phone
+86-13857173887
Email
liuxb2009@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-an Wang, MD,PhD
Phone
+86-13805786328
Email
Wang_jian_an@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-an Wang, MD,PhD
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital, School of Medicine at Zhejiang University
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianbao Liu, PHD
Email
liuxb@zju.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
35413789
Citation
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.
Results Reference
derived
PubMed Identifier
33243378
Citation
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.
Results Reference
derived

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Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

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