NCT02847546

Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic Valve Implantation (TAVI).

Detailed description

The BARD® True™ Flow Valvuloplasty Perfusion Catheter Study is a prospective, single-center, non-randomized, single-arm observational study intended to collect data to confirm the performance and safety of the BARD® True™ Flow Valvuloplasty Perfusion Catheter (True™ Flow catheter) when used for dilatation of the aortic valve in preparation for Transcatheter Aortic Valve Implantation (TAVI). This study will be conducted in conformance with the Declaration of Helsinki, applicable national privacy laws, and European, national regulations and International Organization for Standardization (ISO) requirements (ISO 14155:2011 (E)).

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	True™ Flow Valvuloplasty Perfusion Catheter	Balloon Aortic Valvuloplasty as preparation step in implantation of a Tanscatheter Aortic Valve Implantation (TAVI).

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-07-28
• Last updated: 2017-01-10

Locations

1 site across 1 country: Germany