NCT06211296

The ShortCut™ Continued Access Study Protocol

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pi-cardia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).

Detailed description

The continued access study will be used to collect additional safety and effectiveness data of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.

Conditions

• Valve-in-valve Procedures
• Aortic Stenosis
• Coronary; Obstruction

Interventions

Type	Name	Description
DEVICE	Shortcut	Splitting bioprosthetic aortic valve leaflets

Timeline

• Start date: 2024-07-03
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2024-01-18
• Last updated: 2025-11-17
• Results posted: 2025-11-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study