NCT01956526

CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: CorAssist Cadiovascular Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".

Conditions

• Diastolic Heart Failure NYHA Class III-IV
• Diastolic Dysfunction Secondary to Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	CORolla™ TAA device

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-09-01
• Completion: 2017-09-01
• First posted: 2013-10-08
• Last updated: 2013-10-08

Locations

2 sites across 1 country: Italy