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ArcFlex Sheath in TAVR Trial
Sponsor: Sun Yat-sen University
Summary
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
Official title: ArcFlex Sheath in TAVR Trial(Arc-FIT)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-03-01
Completion Date
2030-03-30
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
ArcFlex Sheath
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
ordinary sheath
ordinary sheath
Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China