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Comparison of TrIfecta and Perimount Magna Ease

NCT03021356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-01-13

No results posted yet for this study

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.

Conditions

  • Aortic Xenograft Hemodynamics

Interventions

DEVICE

Aortic xenograft

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

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Kerckhoff Klinik

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-07-31
Completion
2016-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021356 on ClinicalTrials.gov