NCT05886517

Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: AUSL Romagna Rimini · Academic / Other
• Sex: All
• Age: 75 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by expert operator team, in patients with prohibitive surgical risk. For the pilot phase, 20 patients will be enrolled. For whole study, all consecutive patients undergoing TAVI in center without CS on site will be enrolled to reach a number of about 200 patients.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transfemoral transcatheter aortic valve implementation	ranscatheter aortic valve implantation, a percutaneous treatment for severe aortic valve stenosis, is increasingly performed worldwide. The pacemaker should be able to perform overdrive pacing which is essential to reduce cardiac output and transvalvular blood flow which are critical during balloon aortic valvuloplasty and valve deployment of the balloon- expandable valve. Minor adjustment may be needed for ideal positioning, but importantly this has to be done before valve implantation

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2023-06-02
• Last updated: 2025-02-21

Locations

4 sites across 2 countries: Italy, Spain