Trials / Not Yet Recruiting
Not Yet RecruitingNCT07320274
ArcFlex Sheath in TAVR Trial
ArcFlex Sheath in TAVR Trial(Arc-FIT)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-12-30
- Completion
- 2030-03-30
- First posted
- 2026-01-06
- Last updated
- 2026-01-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07320274. Inclusion in this directory is not an endorsement.