Comparison of TrIfecta and Perimount Magna Ease

Not Applicable

Completed

• Conditions: Aortic Xenograft Hemodynamics
• Interventions: Device: Aortic xenograft

• Registration Number: NCT03021356
• Lead Sponsor: Kerckhoff Klinik

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-07
• Study Completion: 2016-08
• Status Verified: 2017-01
• Study First Submitted: 2017-01-08
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-13
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients between 18 and 75 years

• Elective aortic valve replacement in patients with predominant aortic stenosis

  • including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement

• Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.

• Native German speakers (quality of life questionnaire in German language)

Exclusion Criteria

• Isolated aortic regurgitation
• Concomitant aortic regurgitation > 2°
• Endocarditis
• LVEF <40%
• Concomitant other valve surgery
• s/p valve surgery
• Contraindication for stress echocardiography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trifecta aortic xenograft	Aortic xenograft	The Trifecta aortic xenograft is implanted in these patients.
Magna Ease aortic xenograft	Aortic xenograft	The Magna Ease aortic xenograft is implanted in these patients.

Primary Outcome Measures

Name	Time	Method
Transprosthetic pressure gradient at stress exercise echocardiography	Echo at follow up stress echo (at 10 months)

Secondary Outcome Measures

Name	Time	Method
Quality of life using the EQ-5D-3L questionnaire	1 to 5 days before surgery and at follow up (10 months)
Left ventricular mass regression calculated by echocardiography (gram)	Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)
BNP plasma level	1 to 5 days before surgery and at follow up (10 months)
Transprosthetic pressure gradient at discharge echo	Echo at discharge (usually postoperative day 5 to 7)

Trial Locations

Locations (1)

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany