Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

S

Sorin

Status

Terminated

Conditions

Aortic Valve Disease

Treatments

Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Device: Carpentier-Edwards Magna Tissue Valve

Study type

Interventional

Funder types

Industry

Identifiers

NCT00705913
MRVSS-02

Details and patient eligibility

About

The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.

Full description

Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless

Enrollment

368 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.

Exclusion criteria

  • Less than 18 years of age
  • Emergency Surgery
  • Pre-existing valve prothesis in the aortic position
  • Aortic root replacements or enlargements
  • Active endocarditis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

368 participants in 2 patient groups

1
Active Comparator group
Description:
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Treatment:
Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
2
Active Comparator group
Treatment:
Device: Carpentier-Edwards Magna Tissue Valve

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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