Comparison of TrIfecta and Perimount Magna Ease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03021356
• Date of registration: 08/01/2017
• Prospective Registration: No
• Primary sponsor: Kerckhoff Klinik
• Public title: Comparison of TrIfecta and Perimount Magna Ease
• Scientific title: Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease
• Date of first enrolment: September 2012
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03021356
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Xenograft Hemodynamics

Intervention(s)

Device: Aortic xenograft

Primary Outcome(s)

Transprosthetic pressure gradient at stress exercise echocardiography [Time Frame: Echo at follow up stress echo (at 10 months)]

Secondary Outcome(s)

Transprosthetic pressure gradient at discharge echo [Time Frame: Echo at discharge (usually postoperative day 5 to 7)]

BNP plasma level [Time Frame: 1 to 5 days before surgery and at follow up (10 months)]

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)]

Secondary ID(s)

COTRIP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Jude Medical