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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
Are there results?
Not yet: the study is under way

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.

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 groupRoleWhat they receive
Aortic Stenosis/regurgitationExperimentalTranscatheter 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.

  1. Death from any cause

    Measured: 1 year

Secondary outcomes (13)

  1. stroke

    Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  2. death from cardiac causes

    Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  3. myocardial infarction

    Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  4. repeated hospitalization

    Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years

  5. acute kidney injury

    Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  6. vascular complications

    Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years

  7. bleeding events

    Measured: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years

  8. 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

  9. 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

  10. 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

  11. 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

  12. changes in ascending aorta diameter

    Measured: 1 year,2 years, 3 years, 4 years, 5 years，10 years

  13. 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.

  1. First posted16 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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

  • Tan B, Zhu Q, Liu Q, Sheng W, Ren K, Guo Y, Lin X, Wu F, Cheng S, Zheng C, Liu X. Transcatheter aortic valve replacement in bicuspid versus tricuspid aortic valves among patients with mixed aortic valve disease. BMC Cardiovasc Disord. 2026 Oct 7;26(1):1019. doi: 10.1186/s12872-026-06802-9.

    PubMed 42977929

  • 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianbao Liu, MD (+86-13857173887, liuxb2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death from any cause (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02803294, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.

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