Aortic StenosisPhase 3SOLONCT01115907
Freedom SOLO Stentless Heart Valve Study
A Phase 3 study testing Freedom SOLO Stentless Heart Valve in people with Aortic Stenosis and Aortic Insufficiency, run by Sorin Group USA, Inc. at 15 sites in 2 countries.
Trial summary
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Aortic Insufficiency
- What is being tested?
- Freedom SOLO Stentless Heart Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Dec 2010to Oct 2014
- Phase
- Phase 3
- 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 subject is male or female 18 years old or older.
- The subject or subject's legal representative is willing to sign the informed consent.
- The subject which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
- Any subject 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 subject 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).
- Subject will be available to the investigator(s) for postoperative follow-up beyond one year.
Who cannot join
- The subject has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
- The subject requires a double or multiple valve replacement (a valve repair is not considered an exclusion criterion).
- The subject has a previously implanted SOLO valve, within the clinical study, that requires replacement.
- The subject has active endocarditis or myocarditis.
- The subject is or will be participating in a concomitant research study of an investigational product.
- The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
Show all 15Show fewer
- The subject 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 subject.
- The subject is pregnant, planning to become pregnant or lactating.
- The subject has a congenital bicuspid aortic valve.
- The subject is known to be noncompliant or is unlikely to complete the study.
- The subject is undergoing renal dialysis for chronic renal failure or has been diagnosed with hyperparathyroidism.
- The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
- The subject has extensive calcification of the aortic root where removal of the calcified tissue cannot be achieved.
- The subject has a significantly dilated aortic root that is not surgically corrected.
- The subject requires replacement of the aortic root / full root procedure.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States9 sites
Emory University
Atlanta, Georgia, 30308
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Oakwood Hospital
Dearborn, Michigan, 48124
St. Vincent Heart Center
Indianapolis, Indiana, 46240
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Valley Hospital
Ridgewood, New Jersey, 07450
The Toledo Hospital
Toledo, Ohio, 43606
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Canada6 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
London Health Sciences Centre
London, Ontario
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
University of Bristish Columbia St. Paul Hospital
Vancouver, British Columbia
St. Boniface Hospital
Winnipeg, Manitoba
About this study
Official title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
Read the detailed description
The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the SOLO Freedom heart valve implanted in patients requiring aortic valve replacement.
- Conditions
- Aortic Stenosis, Aortic Insufficiency
- Being tested
- Freedom SOLO Stentless Heart Valve
- Keywords
- Aortic, Valve replacement
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom SOLO Stentless Heart ValveDevice
Freedom SOLO Stentless Heart Valve
| Study group | Role | What they receive |
|---|---|---|
| Freedom SOLO stentless valve implant | Experimental | Appropriate subjects will receive the Freedom SOLO stentless valve implant as a replacement for a diseased or damaged native or prosthetic aortic valve. Receives: Device: Freedom SOLO Stentless Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorin Group USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Roselli, M.D., Principal investigator, The Cleveland ClinicDavid Heimansohn, MD, Principal investigator, St. Vincent Heart CenterAlex Zapolanski, MD, Principal investigator, The Valley HospitalVinod Thourani, MD, Principal investigator, Emory UniversityReza Dabir, MD, Principal investigator, Oakwood HospitalAli Khoynezhad, MD, Principal investigator, Cedars-Sinai Medical CenterPranshanth Vallabhajosyula, MD, Principal investigator, University of PennsylvaniaMichael Moront, MD, Principal investigator, The Toledo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115907
- Sponsor's protocol ID
- G100014
- Acronym
- SOLO
- Status last verified
- Jan 2015
- First submitted
- 29 Apr 2010
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America
- ClinicalTrials.gov ID
- NCT01115907
- Acronym / sponsor ID
- SOLO / G100014
- Conditions
- Aortic Stenosis, Aortic Insufficiency
- Keywords
- Aortic, Valve replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Sorin Group USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 May 2010 (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.
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freedom SOLO stentless valve implant | Experimental | Device: Freedom SOLO Stentless Heart ValveAppropriate subjects will receive the Freedom SOLO stentless valve implant as a replacement for a diseased or damaged native or prosthetic aortic valve. |
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 subject is male or female 18 years old or older.
- The subject or subject's legal representative is willing to sign the informed consent.
- The subject which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
- Any subject 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 subject 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 (15 listed)
- The subject has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
- The subject requires a double or multiple valve replacement (a valve repair is not considered an exclusion criterion).
- The subject has a previously implanted SOLO valve, within the clinical study, that requires replacement.
- The subject has active endocarditis or myocarditis.
- The subject 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 |
|---|---|---|
| Freedom SOLO Stentless Heart ValveFreedom SOLO Stentless Heart Valve | Device | Freedom SOLO stentless valve implant |
Primary outcome
Safety will be determined by incidence rate of adverse events
Time frame: 1 year
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.
2 secondary outcomes
Efficacy will be determined by hemodynamics
Time frame: 1 year
Effectiveness will be determined by NYHA Classification comparisons
Time frame: 1 year
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 26 Jan 2015.
Related trials for Aortic Stenosis
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Eric Roselli, M.D. principal investigator
The Cleveland Clinic
David Heimansohn, MD principal investigator
St. Vincent Heart Center
Alex Zapolanski, MD principal investigator
The Valley Hospital
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Freedom SOLO Stentless Heart Valve in people with Aortic Stenosis and Aortic Insufficiency, run by Sorin Group USA, Inc. at 15 sites in 2 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 15 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety will be determined by incidence rate of adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2015.