Comparison of TrIfecta and Perimount Magna Ease

Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease

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 Overview

• Status: Completed
• Conditions: Aortic Xenograft Hemodynamics
• Intervention / Treatment: Device: Aortic xenograft

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Trifecta aortic xenograft; The Trifecta aortic xenograft is implanted in these patients.	Device: Aortic xenograft; After randomization, the aortic xenograft is implanted in the standard fashion
ACTIVE_COMPARATOR: Magna Ease aortic xenograft; The Magna Ease aortic xenograft is implanted in these patients.	Device: Aortic xenograft; After randomization, the aortic xenograft is implanted in the standard fashion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Kerckhoff Klinik
• Collaborators: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: January 8, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (ESTIMATE): January 13, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: COTRIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO