Clinical trial NCT00705913: Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: aortic valve
heart valve
valve replacement
valve disease
Lead sponsor: Sorin Group USA, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus
timeFrame: 6 months
Secondary outcomes:
measure: Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Tampa
country: United States
facility: Pepin Heart Hospital
state: Florida
city: Kansas City
country: United States
facility: St. Luke's Medical Center
state: Kansas
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Springfield
country: United States
facility: St. John's Medical Research Inst.
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Winnipeg
country: Canada
facility: St.Boniface General Hospital
state: Manitoba
city: Sainte-Foy
country: Canada
facility: Hopital Laval
state: Quebec
Study officials:
References: