The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the SOLO Freedom heart valve implanted in patients requiring aortic valve replacement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
251
Freedom SOLO Stentless Heart Valve
Cedars-Sinai Medical Center
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
St. Vincent Heart Center
Safety will be determined by incidence rate of adverse events
The complication and survival rates for the SOLO valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported in the literature for other stentless bioprostheses and stented pericardial valves.
Time frame: 1 year
Efficacy will be determined by hemodynamics
The hemodynamic performance of the SOLO valve will be compared to that reported in the literature for other stentless bioprostheses and stented pericardial valves.
Time frame: 1 year
Effectiveness will be determined by NYHA Classification comparisons
Clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indianapolis, Indiana, United States
Oakwood Hospital
Dearborn, Michigan, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Foothills Medical Centre
Calgary, Alberta, Canada
...and 5 more locations