NCT04076150

Safety and Performance Study of the Optimum Transcatheter Aortic Valve

A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Thubrikar Aortic Valve, Inc. · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant

Detailed description

The purpose of the study is to assess the safety and performance of the Optimum TAV (Transcatheter Aortic Valve) in patients with symptomatic, severe aortic stenosis who are deemed high-risk for SAVR (Surgical Aortic Valve Replacement) or have contraindications or deemed inoperable for SAVR.

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System	Treating patients with severe symptomatic aortic stenosis via transcatheter aortic valve implantation by implanting the Optimum TAV inside the native diseased valve via a the Precision Catheter. The Optimum TAV and Precision Catheter together are the Optimum TAV System.

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-12-18
• Completion: 2027-05-18
• First posted: 2019-09-03
• Last updated: 2022-09-21

Locations

1 site across 1 country: Poland