Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Aortic Valve Disease Clinical Trial

Official title:

A Randomized Study to Compare Sizing, Implant Techniques and Hemodynamic Performance Between the Mitroflow and the Carpentier-Edwards Magna Pericardial Tissue Valves in the Aortic Position

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00705913
• Other study ID #: MRVSS-02
• Status: Terminated
• Phase: N/A
• First received: June 18, 2008
• Last updated: January 6, 2012
• Start date: June 2008
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Sorin Group USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 368
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Device:
• Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve
• Carpentier-Edwards Magna Tissue Valve
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve

Locations

Country	Name	City	State
Canada	Hopital Laval	Sainte-Foy	Quebec
Canada	St.Boniface General Hospital	Winnipeg	Manitoba
United States	Montefiore Medical Center	Bronx	New York
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Duke University Hospital	Durham	North Carolina
United States	St. Luke's Medical Center	Kansas City	Kansas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	Sharp Memorial Hospital	San Diego	California
United States	St. John's Medical Research Inst.	Springfield	Missouri
United States	Pepin Heart Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sorin Group USA, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus		6 months	No
Secondary	Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.		6 months	No