NCT03021356

Comparison of TrIfecta and Perimount Magna Ease

Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Kerckhoff Klinik · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.

Conditions

• Aortic Xenograft Hemodynamics

Interventions

Type	Name	Description
DEVICE	Aortic xenograft	After randomization, the aortic xenograft is implanted in the standard fashion

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-07-01
• Completion: 2016-08-01
• First posted: 2017-01-13
• Last updated: 2017-01-13

Locations

1 site across 1 country: Germany