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NOT YET RECRUITING
NCT07320274
NA

ArcFlex Sheath in TAVR Trial

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

ordinary sheath

ordinary sheath

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China