Symptomatic Aortic Stenosis Clinical Trial
— TORCHOfficial title:
THE TORCH TRIAL:Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
NCT number | NCT02803294 |
Other study ID # | SAHZJU CT006 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | July 2027 |
The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | July 2027 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital, School of Medicine at Zhejiang University | Hanzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death from any cause | 1 year | ||
Secondary | stroke | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | death from cardiac causes | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | myocardial infarction | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | repeated hospitalization | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years, 10 years | ||
Secondary | acute kidney injury | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | vascular complications | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | bleeding events | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | 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) | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | |
Secondary | Functional Improvement from baseline per New York Heart Association functional classification | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | 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. | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | |
Secondary | transcatheter valve failure | leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | |
Secondary | changes in ascending aorta diameter | 1 year,2 years, 3 years, 4 years, 5 years,10 years | ||
Secondary | Death from all causes | 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years,10 years |
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