Comparison of TrIfecta and Perimount Magna Ease

Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03021356

Enrollment

100

Registered

2017-01-13

Start date

2012-09-30

Completion date

2016-08-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Xenograft Hemodynamics

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.

Interventions

DEVICEAortic xenograft

After randomization, the aortic xenograft is implanted in the standard fashion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Transprosthetic pressure gradient at discharge echo	Echo at discharge (usually postoperative day 5 to 7)
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)
Quality of life using the EQ-5D-3L questionnaire	1 to 5 days before surgery and at follow up (10 months)
BNP plasma level	1 to 5 days before surgery and at follow up (10 months)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026