Recruiting NCT02803294
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcatheter aortic valve replacement.
- Who it may be relevant to
- Registry conditions: Symptomatic Aortic Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
THE TORCH TRIAL：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.
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
Primary outcome measures
- Death from any cause [Time frame: 1 year]
Secondary outcome measures (12)
- 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]
- 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]
- transcatheter valve failure [Time frame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years]
- changes in ascending aorta diameter [Time frame: 1 year,2 years, 3 years, 4 years, 5 years，10 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital, School of Medicine at Zhejiang University — Hanzhou
Publications
- 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. PMID 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. PMID 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. PMID 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. PMID 33243378
Identifiers
NCT: NCT02803294 · SAHZJU CT006