Clinical trial NCT02803294: Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
Official title: THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Symptomatic Aortic Stenosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Death from any cause
timeFrame: 1 year
Secondary outcomes:
measure: stroke
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: death from cardiac causes
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: myocardial infarction
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: repeated hospitalization
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years
measure: acute kidney injury
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: vascular complications
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
measure: bleeding events
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: device success
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: Functional Improvement from baseline per New York Heart Association functional classification
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: permanent pacemaker implantation
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: transcatheter valve failure
timeFrame: 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: changes in ascending aorta diameter
timeFrame: 1 year,2 years, 3 years, 4 years, 5 years，10 years
measure: Death from all causes
timeFrame: 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years，10 years
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The Second Affiliated Hospital, School of Medicine at Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Jian-an Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.