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Severe Aortic StenosisNCT03004599

Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis

A study testing SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in people with Severe Aortic Stenosis, run by Medico's Hirata Inc. at 5 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis Read more about this study

Who is it for?
Any age
Conditions the study is for
Severe Aortic Stenosis
What is being tested?
SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
5 sitesJapan
Study dates
Nov 2016to Oct 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • At least one cardiologist and one cardiac surgeon agree that it is difficult for the patient to receive a surgical procedure due to medical factors such that the subject has various comorbidities and he/she is more likely to die or suffer from severe diseases than to have significant improvements by a surgical procedure.
  • Subject has senile degenerative aortic valve stenosis with:
  • mean gradient > 40 mmHg, or maximum jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization
  • AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
  • Subject is symptomatic from his/her aortic valve stenosis (AS), as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
  • The subject has been informed of the nature of this trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
  • The subject or the subject's legal representative agrees to visit the site where he/she receives index procedure for all required post-procedure follow-ups.

Who cannot join

  • Evidence of an acute myocardial infarction ≤ 30 days (The procedure day is counted as day 0.) before the implant procedure
  • Any percutaneous coronary or peripheral interventional procedures, including placements of bare metal stents are performed within 30 days prior to the implant procedure, or any drug eluting stents are placed within 6 months (One month is counted as 30 days.) prior to the implant procedure
  • Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  • Blood dyscrasias as defined:
  • leukopenia (WBC < 1,000/mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
Show all 38Show fewer
  • Need for emergency surgery for any reason
  • Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to the implant procedure (except mild TIA related to aortic stenosis)
  • End stage renal disease requiring chronic dialysis or serum creatinine > 3.0 mg/dL
  • Active Gastrointestinal (GI) bleeding within 3 months prior to the implant procedure
  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
  • Aspirin
  • Heparin (HIT/HITTS)
  • Nitinol (titanium or nickel)
  • P2Y12 inhibitors (such as Ticlopidine etc.)
  • Contrast media
  • Ongoing sepsis, including active endocarditis
  • Subject refuses a blood transfusion
  • Life expectancy < 12 months due to associated non-cardiac comorbid conditions
  • Other medical, social, or psychological conditions that in the opinion of a principal investigator or sub-investigator precludes the subject from appropriate consent
  • Severe dementia (unable to provide informed consent for the treatment/procedure, unable to live an independent life outside of a chronic care facility, or expected to be fundamentally unable to undergo rehabilitation after the procedure, or unable to come to the site for follow-up visits)
  • Currently participating in other trials of investigational drugs or other investigational devices
  • Native aortic annulus size < 21 mm or > 27 mm per the baseline diagnostic imaging
  • Pre-existing prosthetic heart valve and / or prosthetic ring in any position
  • Mixed aortic valve disease (aortic stenosis and predominant aortic regurgitation (3-4+))
  • Moderate to severe (3-4+) or severe (4+) mitral regurgitation or severe (4+) tricuspid regurgitation
  • Moderate to severe mitral stenosis
  • Hypertrophic obstructive cardiomyopathy
  • New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • Congenital bicuspid or unicuspid valve verified by echocardiograph
  • Extreme eccentric calcification of the native aortic valve
  • Transesophageal echocardiogram (TEE) is contraindicated.
  • Scheduled surgical or percutaneous procedure to be performed prior to 1-month visit post-implant procedure
  • Hepatic failure (Child C or more)
  • Aortic or peripheral condition NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
  • Thoracic or abdominal aortic aneurysm
  • Woman who is pregnant, breastfeeding or willing to become pregnant

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • Sakakibara Heart Institute

    Fuchū, Tokyo, 183-0003

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Keio University Hospital

    Shinjuku, Tokyo, 160-8582

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Teikyo University Hospital

    tabashi City, Tokyo, 173-8606

Other trials in Japan

About this study

Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis

Read the detailed description

To evaluate the safety and efficacy of Transfemoral Transcatheter Aortic Valve Implantation using SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in patients presenting with symptomatic severe aortic stenosis and with difficulty to safely undergo conventional surgical aortic valve replacement (AVR)

Being tested
SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
Keywords
Valvular Heart Disease, Critical Aortic Stenosis, Severe Aortic Stenosis, High Risk, Aortic Valve Replacement, Cardiovascular Disease, Aortic Stenosis, Heart Valve Therapy, Transcatheter, Transfemoral, TAVI, TAVR, ACURATE neo™ Aortic Bioprosthesis, ACURATE TF™ Transfemoral Delivery System
Medical subject headings
Aortic Valve Stenosis, Heart Valve Diseases, Cardiovascular Diseases

What participants receive

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

  • SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery SystemDevice

    Also called ACURATE neo™ Aortic Bioprosthesis, ACURATE TF™ Transfemoral Delivery System

    Transcatheter Aortic Valve Implantation via Transfemoral Approach

Study groups in NCT03004599
Study groupRoleWhat they receive
Transcatheter Aortic Valve Implantation (TAVI)OtherNot described
Receives: Device: SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System

What is being measured

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

  1. Survival rate

    Measured: at 12 months post-procedure

Secondary outcomes (16)

  1. Occurrence rates of MACCE

    MACCE is defined as a composite of:

    • All Cause Mortality
    • Myocardial infarction (MI)
    • All Stroke
    • Reintervention

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  2. Occurrence rates of individual MACCE components

    Individual MACCE components include:

    • All Cause Mortality
    • Myocardial infarction (MI)
    • All Stroke
    • Reintervention

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  3. Occurrence rates of Major Adverse Events (MAEs)

    MAEs include:

    • MACCE
    • Acute Kidney Injury (AKI)
    • Cardiac Tamponade
    • Prosthetic Valve Dysfunction (PVD)
    • Cardiogenic Shock
    • Prosthetic Valve Endocarditis
    • Life-Threatening, Disabling or Major Bleeding
    • Major Vascular Complications
    • Cardiac Perforation
    • Device Migration/Valve Embolism

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  4. Occurrence rate of conduction disturbance requiring Permanent Pacemaker Implantation(PPI)

    Measured: at 1 month, 6 month, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  5. Change in NYHA class from baseline

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  6. Change in distance walked during 6-Minute Walk Test (6MWT) from baseline

    Measured: at 1 month and 12 month post-procedure

  7. Change in QOL from baseline

    Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  8. Change in QOL from baseline

    SF-36

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  9. Echocardiographic assessment of valve performance

    Effective Orifice Area Index (EOAI)

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  10. Echocardiographic assessment of valve performance

    Mean gradient

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  11. Echocardiographic assessment of valve performance

    Degree of Aortic valve Regurgitation (AR) (Transvalvular and Paravalvular)

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  12. Echocardiographic assessment of valve performance

    Left ventricular ejection fraction (LVEF)

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  13. Device success

    Device success is defined as that all of the following are achieved:

    • Successful vascular access
    • Successful delivery and deployment of the device
    • Successful retrieval of the delivery system
    • Correct position of the device in the proper anatomical location (placement in the aortic annulus with no impedance on device function)
    • Intended performance of the prosthetic heart valve is confirmed by echocardiography (defined as below):
    • No Patient-Prosthesis Mismatch (PPM) (EOAI >0.85cm2/m2)
    • And mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec,
    • And no moderate or severe prosthetic valve regurgitation
    • Only one valve implanted in the proper anatomical location

    Measured: Number of days from admission to discharge (estimated to be at 7 days post-procedure on average)

  14. Procedural success

    Procedural success is defined as that all of the following are achieved:

    • Achievement of the device success
    • Absence of in-hospital MACCE

    Measured: Number of days from admission to discharge (estimated to be at 7 days post-procedure on average)

  15. Occurrence rate of Prosthetic Valve Dysfunction (PVD)

    Prosthetic Valve Dysfunction (PVD) is defined as:

    • Aortic regurgitation (AR) reported as moderate or severe by echocardiography assessments
    • Significant aortic stenosis (AS) which meets one or more of the following by echocardiography assessments:
    • Peak velocity > 4 m/s
    • Mean gradient > 35 mmHg
    • Effective Orifice Area (EOA) < 0.8 cm2
    • TVIV1／TVIV2 < 0.25

    Measured: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure

  16. Occurrence rate of clinical endpoints per VARC 2

    • Mortality
    • Stroke
    • Myocardial infarction (MI)
    • Bleeding complications
    • Acute kidney injury (AKI)
    • Vascular complications
    • Conduction disturbances and arrhythmia
    • Other TAVI-related complications

    Measured: at 1 month post-procedure

Timeline

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

  1. First posted29 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionOct 2017
  4. Study completionOct 2017

Why it stopped: Due to the business issues. Manufacturer has been acquired by other company.

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03004599
Sponsor's protocol ID
MH-P-002
Status last verified
Nov 2017
First submitted
9 Dec 2016
Last updated
6 Nov 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in people with Severe Aortic Stenosis, run by Medico's Hirata Inc. at 5 sites in Japan.

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 7 inclusion and 38 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: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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 was stopped early (reason given: Due to the business issues. Manufacturer has been acquired by other company.). 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?

Survival rate (time frame: at 12 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 NCT03004599.

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 Nov 2017.

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