Comparison of TrIfecta and Perimount Magna Ease

Kerckhoff Klinik100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Aortic Xenograft Hemodynamics

Interventions

Aortic xenograftDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Kerckhoff Klinik

Bad Nauheim, Germany

Outcomes

Primary Outcomes

Transprosthetic pressure gradient at stress exercise echocardiography

Time frame: Echo at follow up stress echo (at 10 months)

Secondary Outcomes

Transprosthetic pressure gradient at discharge echo

Time frame: Echo at discharge (usually postoperative day 5 to 7)

Left ventricular mass regression calculated by echocardiography (gram)

Time frame: 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

Time frame: 1 to 5 days before surgery and at follow up (10 months)

BNP plasma level

Time frame: 1 to 5 days before surgery and at follow up (10 months)

Data from ClinicalTrials.gov

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