Comparison of TrIfecta and Perimount Magna Ease

Kerckhoff Klinik

Status: Completed

Conditions: Aortic Xenograft Hemodynamics

Treatments: Device: Aortic xenograft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03021356

COTRIP

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Trifecta aortic xenograft

Active Comparator group

Description:

The Trifecta aortic xenograft is implanted in these patients.

Treatment:

Device: Aortic xenograft

Magna Ease aortic xenograft

Active Comparator group

Description:

The Magna Ease aortic xenograft is implanted in these patients.

Treatment:

Device: Aortic xenograft