Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Symptomatic Aortic Stenosis Clinical Trial

— TORCH  

Official title:

THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02803294
• Other study ID #: SAHZJU CT006
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: July 2027

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xianbao Liu, MD
• Phone: +86-13857173887
• Email: liuxb2009[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Intervention

Procedure:
• transcatheter aortic valve replacement

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, School of Medicine at Zhejiang University	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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