NCT03004599

Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Medico's Hirata Inc. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis

Detailed description

To evaluate the safety and efficacy of Transfemoral Transcatheter Aortic Valve Implantation using SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in patients presenting with symptomatic severe aortic stenosis and with difficulty to safely undergo conventional surgical aortic valve replacement (AVR)

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System	Transcatheter Aortic Valve Implantation via Transfemoral Approach

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-12-29
• Last updated: 2017-11-06

Locations

5 sites across 1 country: Japan