- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876525
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wien, Austria, 1030
- Krankenhaus Hietzing
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Wien, Austria, 1090
- Medical University Vienna
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Bruxelles, Belgium, 1200
- St. Luc Hospital
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Gent, Belgium, 9000
- University Hospital Gent
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Rennes, France, 35033
- Hôpital Pontchaillou - CHU
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Tours, France, 37000
- Hôpital Trousseau - CHRU
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Bad Neustadt An Der Saale, Germany, 97616
- Herz- und Gefäß-Klinik GmbH
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Berlin, Germany, 10117
- Charité Hospital
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Dresden, Germany, 01307
- Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
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Erlangen, Germany, 91054
- Universitätsklinikum Erlangen, Klinik für Herzchirurgie
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Massa, Italy, 54100
- Ospedale del Cuore, Fondazione G. Monasterio
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Treviso, Italy, 31100
- Ospedale "S. Maria di Ca' Foncello"
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Udine, Italy, 33100
- Ospedale S. Maria Della Misericordia
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Amsterdam, Netherlands, 1100 DD
- Academisch Medisch Centrum
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Eindhoven, Netherlands, 5623 EJ
- Catharina Hospital
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Enschede, Netherlands, 7513 ER
- Medisch Spectrum Twente, Thoraxcentrum
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Nijmegen, Netherlands, 6500 HB
- University Hospital St. Radboud
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Porto, Portugal, 4200-319
- Hospital S. João
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Bern, Switzerland, 3010
- Inselspital, University Hospital Berne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patient is male or female 18 years old or older.
- The patient is willing to sign the informed consent.
- The patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
- Any patient amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
- The patient is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
- Patient will be available to the investigator(s) for postoperative follow-up beyond one year.
Exclusion Criteria:
- The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
- The patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion).
- The patient has a previously implanted SOLO valve, within the clinical study, that requires replacement.
- The patient has active endocarditis.
- The patient is or will be participating in a concomitant research study of an investigational product.
- The patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.
- The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
- The patient is pregnant or lactating.
- Patients with congenital bicuspid aortic valve.
- Patients are known to be noncompliant or are unlikely to complete the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Freedom SOLO stentless valve
Prospective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication.
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The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The complication and survival rates for the Freedom SOLO stentless valve.
Time Frame: up to 1 year
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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.
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up to 1 year
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The complication and survival rates for the Freedom SOLO stentless valve.
Time Frame: up to 5 year
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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.
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up to 5 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients
Time Frame: up to 5 year
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Decrease of transvalvular peak and mean pressure gradients from preoperative to follow up
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up to 5 year
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Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography
Time Frame: up to 5 year
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Increase of effective orifice area (EOA) from preoperative to follow up
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up to 5 year
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Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).
Time Frame: up to 5 year
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Increase of effective orifice area index from preoperative to follow up.
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up to 5 year
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Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.
Time Frame: up to 5 year
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Improvement of Cardiac Output
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up to 5 year
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Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.
Time Frame: up to 5 year
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Improvement of Cardiac Index
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up to 5 year
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Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.
Time Frame: up to 5 year
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Evaluation of regurgitation, location and severity
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up to 5 year
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Preoperative and postoperative NYHA functional classifications
Time Frame: Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter
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NYHA functional classification data is presented as the number and percentage of patients in each functional class.
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Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Markus Thalmann, MD, KH Hietzing Wien
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V10604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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