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Aortic Valve StenosisPhase 2SALUSNCT01932099

TranScatheter Aortic Valve RepLacement System US Feasibility Trial

A Phase 2 study testing Transcatheter aortic valve replacement in people with Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair. The delivery of this device is done via the femoral artery. Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Transcatheter aortic valve replacement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
6 sitesUnited States
Study dates
Aug 2013to Dec 2018
Phase
Phase 2
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 patient has severe senile degenerative aortic valve stenosis determined by resting or dobutamine stress echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean gradient >40 mmHg or peak jet velocity >4.0 m/s and an aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2.
  • The patient has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥III).
  • The patient must have a predicted risk of operative mortality or serious irreversible morbidity of >50% at 30 days, or be deemed not suitable for surgery for other reasons. This conclusion shall be based on consensus of one cardiologist and two cardiac surgeons at the investigational site after careful consideration of the patient's STS risk score and co-morbidities, and after at least one of the surgeons participating in the decision has personally examined the patient.
  • The patient been informed of the nature of the study, agrees to its provisions, is willing to comply with protocol-specified follow-up evaluations and has provided written informed consent, approved by the appropriate IRB.

Who cannot join

  • Left ventricular ejection fraction (LVEF) <20% determined by resting echocardiogram
  • Patients with an acute MI within 30 days preceding the index procedure.
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the study procedure
  • Patients with impaired renal function (estimated Glomerular Filtration Rate [eGFR] <20cc/min, calculated from serum creatinine by the Cockcroft-Gault formula)
  • Patients with a platelet count of <50,000 cells/mm³ or a WBC < 1000 cells/mm³ within 7 days prior to index procedure.
  • Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion.
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  • Patients who have received any organ transplant or are on a waiting list for any organ transplant.
  • Patients with known other medical illness (e.g. carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease) or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year, or expectation that patient will not improve despite treatment of aortic stenosis.
  • Patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, and/or contrast sensitivity that cannot be adequately pre-medicated.
  • Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
  • Patients with an active gastrointestinal (GI) bleeding within the prior 6 months.
  • Patients presenting with hemodynamic instability or cardiogenic shock defined by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  • Patients who have a planned treatment with any other investigational device or procedure during the study period, or who are currently participating in an investigational drug or another device trial
  • Any planned surgical, percutaneous coronary or peripheral procedure to be performed prior to the 30 day follow-up from the TAVR procedure.
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Trans-esophageal echocardiography (TEE) is contraindicated
  • Active endocarditis or sepsis within 6 months prior to the study procedure
  • Dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
  • Congenital bicuspid or unicuspid valve determined by echocardiography
  • Prior aortic or mitral valve surgery or pre-existing prosthetic heart valve in any position
  • Native valve annulus diameter is <19mm or >26mm determined by the screening CT scan
  • Extreme asymmetrical calcification of the native aortic valve determined by the screening CT scan
  • Echocardiographic evidence of intra-cardiac mass, thrombus, vegetation, or spontaneous echo contrast in the left atrium
  • >3+ aortic regurgitation, mitral regurgitation or tricuspid regurgitation
  • Moderate to severe mitral stenosis
  • Thoracic aortic aneurysm (TAA) or abdominal aortic aneurysm (AAA) >5.0 cm
  • Presence of an endovascular stent graft for treatment of AAA or TAA 28 Hypertrophic obstructive cardiomyopathy
  • 29. Patients with severe peripheral arterial disease that precludes sheath vascular access (e.g. luminal diameter less than 6.5 mm, severe obstructive calcification or severe tortuosity)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Cleveland CLinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Columbia Univ. Medical Center

    New York, New York, 10032

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Washington University Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: The Direct Flow Medical TranScatheter Aortic Valve RepLacement System US Feasibility Trial

A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair. The delivery of this device is done via the femoral artery.

Read the detailed description

The Direct Flow Medical Transcatheter Aortic Valve System is indicated for symptomatic patients who require replacement of their native aortic valve and have a predicted operative mortality or serious morbidity risk of equal or greater 50% at 30 days with surgical aortic valve replacement or are deemed unsuitable for surgery.

Being tested
Transcatheter aortic valve replacement
Keywords
pathological constriction; restricted outflow, stenosis
Medical subject headings
Aortic Valve Stenosis, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter aortic valve replacementDevice

    Also called Direct Flow Medical aortic valve system, TAVR

    Direct Flow Medical Transcatheter Aortic Valve System is indicated for use in aortic stenosis for patients at extreme surgical risk for aortic valve replacement.

Study groups in NCT01932099
Study groupRoleWhat they receive
Single arm feasibility studyExperimentalProspective, multi-center, single arm feasibility study. Subjects will include patients with severe aortic valve stenosis who require replacement of their native aortic valve. The intervention is transcatheter aortic valve replacement.
Receives: Device: Transcatheter aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from all cause mortality/Device success

    Absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomic location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient less than 20 mmHg or peak velocity less than 3m/s, AND no moderate or severe prosthetic valve regurgitation.

    Measured: 6 months post procedure

Secondary outcomes (4)

  1. Early Safety

    Early Safety: as a composite of

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening bleeding
    • Acute Kidney Injury - Stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complications
    • Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)

    Measured: 30 Days

  2. Clinical Efficacy

    Clinical Efficacy will be evaluated as a composite of:

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Hospitalization for valve-related symptoms or worsening congestive heart failure† (including reporting of days hospitalized)
    • NYHA Class III or IV
    • Prosthetic heart valve dysfunction (mean aortic valve gradient ≥20 mm Hg, EOA ≤0.9-1.1 cm2‡ and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation*)

    Measured: 6 months,and annually at 1 to 5 years

  3. Time-related Valve Safety

    Time-related valve safety will be evaluated as a composite of:

    • Structural valve deterioration:
    • Valve-related dysfunction (mean aortic valve gradient (mean aortic valve gradient ≥20 mm Hg, EOA ≤0.9-1.1 cm2[Depending on body surface area] and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation [VARC defined])
    • Requiring repeat procedure (TAVR or SAVR)
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thromboembolic events (e.g., stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g., trauma)

    Measured: 30 days, 6 months and annually at 1 to 5 years

  4. Clinical Endpoints

    Individual Endpoints

    • All-cause mortality
    • Cardiovascular mortality
    • Non-cardiovascular mortality Myocardial Infarction
    • Peri-procedural MI (<72 hours after the index procedure)
    • Spontaneous MI (>72 hours after the index procedure) Neurological Events
    • Stroke
    • Ischemic stroke
    • Hemorrhagic stroke
    • Undetermined
    • Disabling Stroke
    • Non-disabling stroke
    • Transient ischemic attack Bleeding Complications
    • Life-threatening or disabling bleeding
    • Major bleeding
    • Minor bleeding Acute Kidney Injury (AKIN Classification)
    • Stage 1 acute kidney injury
    • Stage 2 acute kidney injury
    • Stage 3 acute kidney injury Vascular Complications
    • Major vascular complications
    • Minor vascular complications
    • Percutaneous closure device failure Prosthetic Valve Dysfunction
    • Prosthetic Aortic Valve Stenosis
    • Prosthesis-Patient Mismatch
    • Prosthetic Aortic Valve Regurgitation

    Measured: 30 days, 6 months and annually at 1 to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionJun 2014
  4. Study completionDec 2018 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01932099
Sponsor's protocol ID
IP 011
Other IDs
G120160
Acronym
SALUS
Status last verified
Oct 2016
First submitted
20 Aug 2013
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcatheter aortic valve replacement in people with Aortic Valve Stenosis, run by Direct Flow Medical, Inc. at 6 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 4 inclusion and 28 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

Freedom from all cause mortality/Device success (time frame: 6 months post procedure). 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 NCT01932099.

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 31 Oct 2016.

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SALUS Clinical Trial NCT01932099 | AzTrials