Aortic Valve StenosisSALUSNCT02163850
Transcatheter Aortic Valve Replacement System Pivotal Trial
A study testing Direct Flow Medical and Commercially Available in people with Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 3 sites in United States.
Trial summary
Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Direct Flow Medical and Commercially Available
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 878 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2015to Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject has severe senile degenerative aortic valve stenosis determined by echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean aortic gradient ≥40 mmHg, or an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2.
- The subject has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥II).
- Subject has a documented aortic annulus size of ≥22 mm and <29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Patient Review Committee [PRC]) and is deemed treatable with an available size of both test and control device.
- There is agreement by the heart team (which must include a site cardiac interventionalist and two cardiac surgeons which can be either two cardiac surgeon staff members at the hospital where the procedure is to be performed or one surgeon from the hospital where the procedure is to be performed and a surgeon from the referring institution or practice) that subject is at high operative risk or greater of serious morbidity or mortality with surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and PRC confirmation) and that TAVR is appropriate. Subjects will be designated either extreme risk (defined as a mortality or irreversible morbidity 50% or great at 30 days) or high risk (i.e., Society of Thoracic Surgeons operative risk score >8% or at a > 15% risk of surgical mortality at 30 days but not extreme risk). This conclusion shall be based on consensus of one cardiac interventionalist and two cardiac surgeons that have reviewed the case after careful consideration of the Subject's STS risk score and co-morbidities.
- Subject understands the study requirements and the treatment procedures, and provides written informed consent.
- Subject agrees and is capable of returning to the study hospital for all required scheduled follow up visits.
Who cannot join
- Left ventricular ejection fraction (LVEF) <20% determined by resting echocardiogram.
- Subjects with an acute STEMI within 30 days preceding the index procedure.
- Chronic kidney disease with creatinine clearance < 20 ml/min.
- Subjects with a platelet count of <50,000 cells/mm³ or a WBC < 1000 cells/mm³ within 7 days prior to index procedure.
- Subject has a known contraindication or hypersensitivity to all antithrombin regimens (aspirin, all P2Y12 inhibitors) that cannot be adequately pretreated, or inability to be anti-coagulated for the study procedure. Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel.
- Any subject with a balloon valvuloplasty (BAV) within 72 hours prior to the index procedure.
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- Subjects who are on a waiting list for any organ transplant.
- Subjects with known other medical illness associated with a life expectancy of less than one year, or expectation that subject will not improve despite treatment of aortic stenosis.
- Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to nickel, tantalum, titanium, or polyurethanes.
- Subjects with a history of a stroke or transient ischemic attack (TIA) within previous 60 days of index procedure.
- Subjects with an active gastrointestinal (GI) bleed or bleeding precluding dual antiplatelet therapy.
- Subjects presenting with hemodynamic instability or cardiogenic shock requiring inotropic support or mechanical support devices.
- Subjects who have a planned treatment with any other investigational device or procedure through 1 year follow-up, or who are currently participating in an investigational drug or another device trial.
- Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TAVR procedure.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Newly identified left atrial thrombus that has not been treated.
- Active endocarditis or sepsis within 6 months prior to the study procedure.
- Any condition resulting in inability to provide informed consent for the trial or difficulty in assessment of neurologic status.
- Congenital bicuspid or unicuspid valve.
- Prior aortic valve surgery or pre-existing prosthetic heart valve in any position (mitral and tricuspid rings are permissible).
- A native valve annulus diameter <22mm or >29mm determined by the screening CT scan.
- Echocardiographic evidence of new intra-cardiac mass, untreated thrombus, or vegetation that requires treatment.
- >3+: aortic regurgitation, mitral regurgitation or tricuspid regurgitation.
- Severe mitral or tricuspid stenosis.
- Thoracic aortic aneurysm (TAA) >5.50 cm.
- Inability to transfuse blood.
- Subject has femoral arterial access that is not acceptable for the study as defined in the device Instructions for Use.
- Coronary anatomy that precludes the perfusion of native coronary arteries post-implant.
- Prohibitive left ventricular outflow tract (LVOT) calcification that would prevent proper deployment of a transcatheter valve.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
Scott Lim, M.D.
Gorav Ailawadi, M.D.
- Recruiting
Ohio Health Riverside Methodist
Columbus, Ohio, 43214
Daniel Watson, M.D.
Steven Yakubov, M.D.
- Recruiting
NewYork-Presbyterian / Columbia Univ.
New York, New York, 10032
Isaac George, M.D.
Susheel Kodali, M.D.
About this study
Official title: SALUS Trial TranScatheter Aortic Valve RepLacement System Pivotal Trial The Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System
Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic self-expanding bioprosthesis or Edwards balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic aortic stenosis. Subjects will be followed through the index procedure, hospital discharge, and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual follow-up at 2 through 5 years will be conducted and analyzed separately.
Read the detailed description
Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic self-expanding bioprosthesis or Edwards balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic aortic stenosis. Subjects will be followed through the index procedure, hospital discharge, and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual follow-up at 2 through 5 years will be conducted and analyzed separately.
The primary study endpoint is a composite of all-cause mortality, disabling stroke, or moderate or greater residual aortic regurgitation (based on core lab assessment) at 1 year. All primary endpoint events will be evaluated by a CEC using the definitions located in this protocol.
A sample size of 648 subjects (432 subjects in Direct Flow Medical Transcatheter Aortic Valve System cohort + 216 subjects in blended control cohort) will provide at least 85% power to test that the study device is non-inferior to the comparator with non-inferiority margin of 10%.
Subjects must meet the fundamental enrollment criteria of severe symptomatic, calcific aortic stenosis with quantifiable and documented source records.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Direct Flow Medical, Commercially Available
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Flow MedicalDevice
Also called TAVR
Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)
Commercially AvailableDevice
Also called TAVR
Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)
| Study group | Role | What they receive |
|---|---|---|
| Direct Flow Medical | Experimental | Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR) Receives: Device: Direct Flow Medical |
| Commercially Available | Active comparator | Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR) Receives: Device: Commercially Available |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death (all cause) and disabling stroke.
The primary study endpoint is a composite of all-cause mortality, disabling stroke, or moderate or greater residual aortic regurgitation (based on core lab assessment) at 1 year.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 878 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direct Flow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Lim, M.D., Principal investigator, Associate Professor of Pediatrics and Medicine and Director of Advanced Cardiac Valve Center at University of VirginiaIsacc George, Principal investigator, Columbia University, Assitant Professor of Surgery Division of Cadiothoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163850
- Sponsor's protocol ID
- IP 011, G120160
- Acronym
- SALUS
- Status last verified
- Apr 2016
- First submitted
- 10 Jun 2014
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SALUS Trial TranScatheter Aortic Valve RepLacement System Pivotal Trial The Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System
- ClinicalTrials.gov ID
- NCT02163850
- Acronym / sponsor ID
- SALUS / IP 011, G120160
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 878 participants (estimated)
- Lead sponsor
- Direct Flow Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Jun 2014 (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.
Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic self-expanding bioprosthesis or Edwards balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic aortic stenosis. Subjects will be followed through the index procedure, hospital discharge, and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual follow-up at 2 through 5 years will be conducted and analyzed separately.
Detailed description
Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial comparator (using approved Medtronic self-expanding bioprosthesis or Edwards balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic aortic stenosis. Subjects will be followed through the index procedure, hospital discharge, and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual follow-up at 2 through 5 years will be conducted and analyzed separately.
The primary study endpoint is a composite of all-cause mortality, disabling stroke, or moderate or greater residual aortic regurgitation (based on core lab assessment) at 1 year. All primary endpoint events will be evaluated by a CEC using the definitions located in this protocol.
A sample size of 648 subjects (432 subjects in Direct Flow Medical Transcatheter Aortic Valve System cohort + 216 subjects in blended control cohort) will provide at least 85% power to test that the study device is non-inferior to the comparator with non-inferiority margin of 10%.
Subjects must meet the fundamental enrollment criteria of severe symptomatic, calcific aortic stenosis with quantifiable and documented source records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Flow Medical | Experimental | Device: Direct Flow MedicalDirect Flow Medical Transcatheter Aortic Valve Replacement System (TAVR) |
| Commercially Available | Active comparator | Device: Commercially AvailableMedtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The subject has severe senile degenerative aortic valve stenosis determined by echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean aortic gradient ≥40 mmHg, or an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2.
- The subject has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥II).
- Subject has a documented aortic annulus size of ≥22 mm and <29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Patient Review Committee [PRC]) and is deemed treatable with an available size of both test and control device.
- There is agreement by the heart team (which must include a site cardiac interventionalist and two cardiac surgeons which can be either two cardiac surgeon staff members at the hospital where the procedure is to be performed or one surgeon from the hospital where the procedure is to be performed and a surgeon from the referring institution or practice) that subject is at high operative risk or greater of serious morbidity or mortality with surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and PRC confirmation) and that TAVR is appropriate. Subjects will be designated either extreme risk (defined as a mortality or irreversible morbidity 50% or great at 30 days) or high risk (i.e., Society of Thoracic Surgeons operative risk score >8% or at a > 15% risk of surgical mortality at 30 days but not extreme risk). This conclusion shall be based on consensus of one cardiac interventionalist and two cardiac surgeons that have reviewed the case after careful consideration of the Subject's STS risk score and co-morbidities.
- Subject understands the study requirements and the treatment procedures, and provides written informed consent.
Key exclusion criteria (29 listed)
- Left ventricular ejection fraction (LVEF) <20% determined by resting echocardiogram.
- Subjects with an acute STEMI within 30 days preceding the index procedure.
- Chronic kidney disease with creatinine clearance < 20 ml/min.
- Subjects with a platelet count of <50,000 cells/mm³ or a WBC < 1000 cells/mm³ within 7 days prior to index procedure.
- Subject has a known contraindication or hypersensitivity to all antithrombin regimens (aspirin, all P2Y12 inhibitors) that cannot be adequately pretreated, or inability to be anti-coagulated for the study procedure. Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel.
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 |
|---|---|---|
| Direct Flow MedicalAlso: TAVRDirect Flow Medical Transcatheter Aortic Valve Replacement System (TAVR) | Device | Direct Flow Medical |
| Commercially AvailableAlso: TAVRMedtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR) | Device | Commercially Available |
Primary outcome
Death (all cause) and disabling stroke.
Time frame: 12 Months
The primary study endpoint is a composite of all-cause mortality, disabling stroke, or moderate or greater residual aortic regurgitation (based on core lab assessment) at 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Scott Lim, M.D. principal investigator
Associate Professor of Pediatrics and Medicine and Director of Advanced Cardiac Valve Center at University of Virginia
Isacc George principal investigator
Columbia University, Assitant Professor of Surgery Division of Cadiothoracic Surgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Flow Medical and Commercially Available in people with Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 3 sites in United States.
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 29 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: status not confirmed, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Edwards (707-576-0420 ext. 462, medwards@directflowmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (all cause) and disabling stroke. (time frame: 12 Months). 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 3 May 2016.