NCT06680427

Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: MiRus · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.

Detailed description

The Siegel™ Transcatheter Aortic Valve (TAVR) Early Feasibility Study is a prospective, non-randomized, single-arm, multi-center study conducted in the US. The primary objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.

Conditions

• Aortic Stenosis Symptomatic

Interventions

Type	Name	Description
DEVICE	Siegel Transcatheter Aortic Valve (TAVR)	Replacement of native aortic valve with the Siegel Transcatheter Aortic Valve (TAVR) by a transfemoral approach.

Timeline

• Start date: 2025-03-26
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-11-08
• Last updated: 2025-12-03

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study