NCT01634269

Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis

Medtronic MDT-2111 CoreValve Japan 23mm Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.

Detailed description

The purpose of this trial is to evaluate the effectiveness and safety of the MDT-2111 TAV system in subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention. The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 New York Heart Association (NYHA) class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	MDT-2111 TAVI 23 mm	Device: 23 mm MDT-2111 System for Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-02-01
• Completion: 2019-09-01
• First posted: 2012-07-06
• Last updated: 2019-10-15
• Results posted: 2018-12-17

Locations

4 sites across 1 country: Japan