Back to resultsClinical Investigation of the Freedom SOLO Stentless Heart Valve
Primary Purpose
Heart Valve Diseases
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Heart Valve Diseases focused on measuring Heart diseases., Aortic valve diseases., Aortic valve insufficiency., Aortic valve stenosis.
Eligibility Criteria
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.
Sites / Locations
- Krankenhaus Hietzing
- Medical University Vienna
- St. Luc Hospital
- University Hospital Gent
- Hôpital Pontchaillou - CHU
- Hôpital Trousseau - CHRU
- Herz- und Gefäß-Klinik GmbH
- Charité Hospital
- Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
- Universitätsklinikum Erlangen, Klinik für Herzchirurgie
- Ospedale del Cuore, Fondazione G. Monasterio
- Ospedale "S. Maria di Ca' Foncello"
- Ospedale S. Maria Della Misericordia
- Academisch Medisch Centrum
- Catharina Hospital
- Medisch Spectrum Twente, Thoraxcentrum
- University Hospital St. Radboud
- Hospital S. João
- Inselspital, University Hospital Berne
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Freedom SOLO stentless valve
Arm Description
Prospective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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
Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).
Increase of effective orifice area index from preoperative to follow up.
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.
Improvement of Cardiac Output
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.
Improvement of Cardiac Index
Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.
Evaluation of regurgitation, location and severity
Preoperative and postoperative NYHA functional classifications
NYHA functional classification data is presented as the number and percentage of patients in each functional class.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00876525
Brief Title
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Official Title
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcym S.r.l
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
Heart diseases., Aortic valve diseases., Aortic valve insufficiency., Aortic valve stenosis.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-randomized, multicenter trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
702 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Freedom SOLO stentless valve
Arm Type
Other
Arm Description
Prospective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication.
Intervention Type
Device
Intervention Name(s)
Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
Intervention Description
The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.
Primary Outcome Measure Information:
Title
The complication and survival rates for the Freedom SOLO stentless valve.
Description
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
Title
The complication and survival rates for the Freedom SOLO stentless valve.
Description
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
Secondary Outcome Measure Information:
Title
Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients
Description
Decrease of transvalvular peak and mean pressure gradients from preoperative to follow up
Time Frame
up to 5 year
Title
Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography
Description
Increase of effective orifice area (EOA) from preoperative to follow up
Time Frame
up to 5 year
Title
Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).
Description
Increase of effective orifice area index from preoperative to follow up.
Time Frame
up to 5 year
Title
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.
Description
Improvement of Cardiac Output
Time Frame
up to 5 year
Title
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.
Description
Improvement of Cardiac Index
Time Frame
up to 5 year
Title
Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.
Description
Evaluation of regurgitation, location and severity
Time Frame
up to 5 year
Title
Preoperative and postoperative NYHA functional classifications
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Thalmann, MD
Organizational Affiliation
KH Hietzing Wien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Hietzing
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Medical University Vienna
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
St. Luc Hospital
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hôpital Pontchaillou - CHU
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital Trousseau - CHRU
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Herz- und Gefäß-Klinik GmbH
City
Bad Neustadt An Der Saale
ZIP/Postal Code
97616
Country
Germany
Facility Name
Charité Hospital
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Klinik für Herzchirurgie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Ospedale del Cuore, Fondazione G. Monasterio
City
Massa
ZIP/Postal Code
54100
Country
Italy
Facility Name
Ospedale "S. Maria di Ca' Foncello"
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Ospedale S. Maria Della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Medisch Spectrum Twente, Thoraxcentrum
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
University Hospital St. Radboud
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Hospital S. João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Inselspital, University Hospital Berne
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26443880
Citation
Thalmann M, Grubitzsch H, Matschke K, Glauber M, Tan E, Francois K, Amorim MJ, Hensens AG, Cesari F, Feyrer R, Diegeler A, Veit F, Repossini A; Freedom Solo Investigators. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis. Ann Thorac Surg. 2016 Jan;101(1):100-8. doi: 10.1016/j.athoracsur.2015.06.096. Epub 2015 Oct 9.
Results Reference
result
Learn more about this trial
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
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