Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna - Full Text View

Sponsored by:	CarboMedics Inc.
Information provided by:	CarboMedics Inc.
ClinicalTrials.gov Identifier:	NCT00705913

Purpose

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.

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by CarboMedics Inc.:

Primary Outcome Measures:

Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	384
Study Start Date:	June 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Mitroflow Aortic Pericardial Heart Valve (CarboMedics)	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
2: Active Comparator	Device: Carpentier-Edwards Magna Tissue Valve Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705913

Contacts

Contact: Barbara P. Mathews, BSN, MSN	512-435-3602	barbara.mathews@sorin.com
Contact: John Villarreal, BA	512-435-3207	john.villarreal@sorin.com

Locations

United States, California
Sharp Memorial Hospital	Not yet recruiting
San Diego, California, United States, 92123
Contact: Debbie King 858-300-4747 debbiecking@hotmail.com
Principal Investigator: Sam Baradarian, MD
United States, Maryland
Peninsula Regional Medical Center	Not yet recruiting
Salisbury, Maryland, United States, 21801
Contact: Lori Short 410-543-7530 shortnurse@netzero.com
Principal Investigator: Michael Todd, MD
United States, Missouri
St. John's Medical Research Inst.	Not yet recruiting
Springfield, Missouri, United States, 65807
Contact: Rebecca Baker 417-820-4184 Rebecca.baker@Mercy.net
Principal Investigator: Sirish Parvathaneni, MD
United States, North Carolina
Duke University Hospital	Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Terry Ainsworth 919-668-2382 ainsw001@mc.duke.edu
Principal Investigator: Chad Hughes, MD
United States, Ohio
The Ohio State University Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Danielle Jones 614-336-8506 Danielle.Jones@osumc.edu
Principal Investigator: Michael Firstenberg, MD
United States, Oregon
Providence St. Vincents Medical Center	Recruiting
Portland, Oregon, United States, 97225
Contact: Eric Johnson 503-216-2075 eric.johnson@providence.org
Principal Investigator: Jeffrey Swanson, MD
United States, Pennsylvania
Hospital of the University of Pennsylvania	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristen Burtch 215-429-3432 Kristen.Burtch@uphs.upenn.edu
Principal Investigator: Joseph Bavaria, MD
United States, Texas
The Heart Hospital Baylor Plano	Recruiting
Plano, Texas, United States, 75093
Contact: Shannon Hoffman 469-814-3466 shannhof@baylorhealth.edu
Principal Investigator: William Ryan, MD
Canada, Manitoba
St.Boniface General Hospital	Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Rachel Gerstein 204-237-2793 rgerstein@sbgh.mb.ca
Principal Investigator: John Lee, MD

Sponsors and Collaborators

CarboMedics Inc.

More Information

Responsible Party:	CarboMedics Inc. ( Barbara Mathews/Senior Director Clinical Research )
Study ID Numbers:	MRVSS-02
Study First Received:	June 18, 2008
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00705913
Health Authority:	United States: Institutional Review Board

Keywords provided by CarboMedics Inc.:

aortic valve
heart valve
valve replacement
valve disease

ClinicalTrials.gov processed this record on January 16, 2009