This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Freedom SOLO study is a prospective, non-randomized, multicenter trial on the Freedom SOLOvalve implanted in patients requiring aortic valve replacement. The study was conducted at 18 centers in Europe. The study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria (OPCs). Based on the guidelines established by the U.S. Food and Drug Administration (FDA), the minimum sample size for this study was 800 valve-years, which is the minimum amount of data needed to test against the OPC of 1.2 %/patient-year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
702
The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.
Krankenhaus Hietzing
Vienna, Austria
Medical University Vienna
Vienna, Austria
The complication and survival rates for the Freedom SOLO stentless valve.
Safety of the Freedom SOLO was evaluated based on the following adverse events related to cardiac valve replacement: valve thrombosis, thromboembolism, bleeding, anticoagulant-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, nonstructural dysfunction, structural valve deterioration, reoperation, explant, and death.
Time frame: up to 1 year
The complication and survival rates for the Freedom SOLO stentless valve.
Safety of the Freedom SOLO was evaluated based on the following adverse events related to cardiac valve replacement: valve thrombosis, thromboembolism, bleeding, anticoagulant-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, nonstructural dysfunction, structural valve deterioration, reoperation, explant, and death.
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients
Decrease of transvalvular peak and mean pressure gradients from preoperative to follow up
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography
Increase of effective orifice area (EOA) from preoperative to follow up
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).
Increase of effective orifice area index from preoperative to follow up.
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Luc Hospital
Brussels, Belgium
University Hospital Gent
Ghent, Belgium
Hôpital Pontchaillou - CHU
Rennes, France
Hôpital Trousseau - CHRU
Tours, France
Herz- und Gefäß-Klinik GmbH
Bad Neustadt an der Saale, Germany
Charité Hospital
Berlin, Germany
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
Dresden, Germany
Universitätsklinikum Erlangen, Klinik für Herzchirurgie
Erlangen, Germany
...and 9 more locations
Improvement of Cardiac Output
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.
Improvement of Cardiac Index
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.
Evaluation of regurgitation, location and severity
Time frame: up to 5 year
Preoperative and postoperative NYHA functional classifications
NYHA functional classification data is presented as the number and percentage of patients in each functional class.
Time frame: Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter