Symptomatic Aortic StenosisPhase 4TORCHNCT02803294

Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

A Phase 4 study testing transcatheter aortic valve replacement in people with Symptomatic Aortic Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Symptomatic Aortic Stenosis
What is being tested?: transcatheter aortic valve replacement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 1 siteChina
Study dates: Jun 2016to Jul 2027
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianbao Liu, MD contact

+86-13857173887

liuxb2009@hotmail.com

Jian-an Wang, MD,PhD contact

+86-13805786328

Wang_jian_an@tom.com

China1 site, 1 recruiting

The Second Affiliated Hospital, School of Medicine at Zhejiang University
Hanzhou, Zhejiang, 310000
Xianbao Liu, PHD, liuxb@zju.edu.cn
Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Symptomatic Aortic Stenosis
Being tested: transcatheter aortic valve replacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcatheter aortic valve replacementProcedure or surgery

Study groups in NCT02803294
Study group	Role	What they receive
Aortic Stenosis/regurgitation	Experimental	Transcatheter aortic valve replacement Receives: Procedure: transcatheter aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

Death from any cause
Measured: 1 year

Secondary outcomes (13)

stroke
Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
death from cardiac causes
Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
myocardial infarction
Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
repeated hospitalization
Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years
acute kidney injury
Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
vascular complications
Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
bleeding events
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
changes in ascending aorta diameter
Measured: 1 year,2 years, 3 years, 4 years, 5 years，10 years
Death from all causes
Measured: 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years，10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Jul 2027

First posted16 Jun 2016 (estimated)
Study startJun 2016
Primary completionJul 2026 (estimated)
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Symptomatic Aortic StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02803294
Sponsor's protocol ID: SAHZJU CT006
Acronym: TORCH
Status last verified: Jul 2021
First submitted: 7 Jun 2016
Last updated: 15 Jul 2021
Results posted: No
Data monitoring committee: Yes

Publications

Yang D, Wu F, Zhu Q, Zhan Y, Mao Y, Liu X. [Effects of digital-driven cardiac rehabilitation on clinical outcomes in patients undergoing transcatheter aortic valve replacement]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2026 Sep 4:1-9. doi: 10.3724/zdxbyxb-2026-0179. Online ahead of print. Chinese.
PubMed 42695202
Fan J, Chen J, Zhu G, Xu Y, Ng S, Dai H, Zhou D, Yidilisi A, Qi X, Liu X, Wang J. Impact of repositioning on brain injury following transcatheter aortic valve replacement with a self-expanding valve. Sci Rep. 2024 Jul 30;14(1):17554. doi: 10.1038/s41598-024-67748-6.
PubMed 39080364
Zhou Q, Wen J, Zhu Q, Fan J, Guan X, Chen X, He Y, Guo Y, Jiang J, Ding X, Pu Z, Huang Z, Li C, Zhang M, Liu X, Xu X, Wang J. Long-term prosthetic-associated subclinical thrombotic events evaluation by cardiac CTA after transcatheter aortic valve implantation: incidence and outcomes. Insights Imaging. 2024 May 30;15(1):125. doi: 10.1186/s13244-024-01681-0.
PubMed 38816554
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.
PubMed 35413789
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.
PubMed 33243378

Interested in taking part?

Xianbao Liu, MD

+86-13857173887

liuxb2009@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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