Heart Valve DiseasesNCT00876525
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
A study testing Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis in people with Heart Valve Diseases, run by Corcym S.r.l at 19 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Mar 2009to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Germany4 sites
Herz- und Gefäß-Klinik GmbH
Bad Neustadt an der Saale, 97616
Charité Hospital
Berlin, 10117
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
Dresden, 01307
Universitätsklinikum Erlangen, Klinik für Herzchirurgie
Erlangen, 91054
Netherlands4 sites
Academisch Medisch Centrum
Amsterdam, 1100 DD
Catharina Hospital
Eindhoven, 5623 EJ
Medisch Spectrum Twente, Thoraxcentrum
Enschede, 7513 ER
University Hospital St. Radboud
Nijmegen, 6500 HB
Italy3 sites
Ospedale del Cuore, Fondazione G. Monasterio
Massa, 54100
Ospedale "S. Maria di Ca' Foncello"
Treviso, 31100
Ospedale S. Maria Della Misericordia
Udine, 33100
Austria2 sites
Krankenhaus Hietzing
Vienna, 1030
Medical University Vienna
Vienna, 1090
Belgium2 sites
St. Luc Hospital
Brussels, 1200
University Hospital Gent
Ghent, 9000
France2 sites
Hôpital Pontchaillou - CHU
Rennes, 35033
Hôpital Trousseau - CHRU
Tours, 37000
About this study
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.
Read the 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.
- Conditions
- Heart Valve Diseases
- Being tested
- Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
- Keywords
- Heart diseases., Aortic valve diseases., Aortic valve insufficiency., Aortic valve stenosis.
- Medical subject headings
- Heart Valve Diseases, Heart Diseases, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesisDevice
The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.
| Study group | Role | What they receive |
|---|---|---|
| Freedom SOLO stentless valve | Other | Prospective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication. Receives: Device: Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 5 year
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.
Improvement of Cardiac Output
Measured: 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
Measured: 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
Measured: 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.
Measured: Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, multicenter trial
- Masking
- None (open label)
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Thalmann, MD, Principal investigator, KH Hietzing Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876525
- Sponsor's protocol ID
- V10604
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2009
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26443880
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Freedom SOLO Stentless Heart Valve
- ClinicalTrials.gov ID
- NCT00876525
- Acronym / sponsor ID
- V10604
- Conditions
- Heart Valve Diseases
- Keywords
- Heart diseases., Aortic valve diseases., Aortic valve insufficiency., Aortic valve stenosis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Freedom SOLO stentless valve | Other | Device: Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesisProspective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesisThe Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line. | Device | Freedom SOLO stentless valve |
Primary outcome
The complication and survival rates for the Freedom SOLO stentless valve.
Time frame: up to 1 year
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.
Time frame: up to 5 year
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.
7 secondary outcomes
Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.
Time frame: up to 5 year
Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.
Time frame: up to 5 year
Preoperative and postoperative NYHA functional classifications
Time frame: Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Results publication: PubMed 26443880Thalmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Thalmann, MD principal investigator
KH Hietzing Wien
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis in people with Heart Valve Diseases, run by Corcym S.r.l at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Netherlands, Italy, Austria, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complication and survival rates for the Freedom SOLO stentless valve. (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.