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TerminatedNCT03004599Updated Nov 6, 2017

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

An interventional study of SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in Severe Aortic Stenosis, sponsored by Medico's Hirata Inc.. Terminated at 5 sites in Japan. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Medico's Hirata Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to the business issues. Manufacturer has been acquired by other company.
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Sex
All
01

Study summary

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)

02

Conditions studied

  • Severe Aortic Stenosis

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
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 11 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

This is the only study on the registry with Medico's Hirata Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.

  2. 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
  3. Subject is symptomatic from his/her aortic valve stenosis (AS), as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
  4. 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.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Evidence of an acute myocardial infarction ≤ 30 days (The procedure day is counted as day 0.) before the implant procedure
  2. 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
  3. Untreated clinically significant coronary artery disease (CAD) requiring revascularization

  4. Blood dyscrasias as defined:

    leukopenia (WBC \< 1,000/mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy

  5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  6. Need for emergency surgery for any reason
  7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram
  8. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to the implant procedure (except mild TIA related to aortic stenosis)
  9. End stage renal disease requiring chronic dialysis or serum creatinine > 3.0 mg/dL
  10. Active Gastrointestinal (GI) bleeding within 3 months prior to the implant procedure

  11. 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
  12. Ongoing sepsis, including active endocarditis
  13. Subject refuses a blood transfusion
  14. Life expectancy \< 12 months due to associated non-cardiac comorbid conditions
  15. Other medical, social, or psychological conditions that in the opinion of a principal investigator or sub-investigator precludes the subject from appropriate consent
  16. 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)
  17. Currently participating in other trials of investigational drugs or other investigational devices
  18. Native aortic annulus size \< 21 mm or > 27 mm per the baseline diagnostic imaging
  19. Pre-existing prosthetic heart valve and / or prosthetic ring in any position
  20. Mixed aortic valve disease (aortic stenosis and predominant aortic regurgitation (3-4+))
  21. Moderate to severe (3-4+) or severe (4+) mitral regurgitation or severe (4+) tricuspid regurgitation
  22. Moderate to severe mitral stenosis
  23. Hypertrophic obstructive cardiomyopathy
  24. New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation
  25. Congenital bicuspid or unicuspid valve verified by echocardiograph
  26. Extreme eccentric calcification of the native aortic valve
  27. Transesophageal echocardiogram (TEE) is contraindicated.
  28. Scheduled surgical or percutaneous procedure to be performed prior to 1-month visit post-implant procedure
  29. Hepatic failure (Child C or more)
  30. 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
  31. Thoracic or abdominal aortic aneurysm
  32. Woman who is pregnant, breastfeeding or willing to become pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Other
    Transcatheter Aortic Valve Implantation (TAVI)

    Device: SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System

Interventions

  • DeviceSYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System

    Transcatheter Aortic Valve Implantation via Transfemoral Approach

    Also known as: ACURATE neo™ Aortic Bioprosthesis, ACURATE TF™ Transfemoral Delivery System

06

What researchers measure

Primary outcomes

  1. Survival rate

    Time frame: at 12 months post-procedure

Secondary outcomes

  1. Occurrence rates of MACCE

    MACCE is defined as a composite of: * All Cause Mortality * Myocardial infarction (MI) * All Stroke * Reintervention

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: at 1 month and 12 month post-procedure

  7. Change in QOL from baseline

    Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: at 1 month post-procedure

07

Study locations

5 sites
  • Kokura Memorial Hospital
    Kitakyushu, Fukuoka 802-8555, Japan
  • Osaka University Hospital
    Suita, Osaka 565-0871, Japan
  • Sakakibara Heart Institute
    Fuchu, Tokyo 183-0003, Japan
  • Teikyo University Hospital
    Itabashi, Tokyo 173-8606, Japan
  • Keio University Hospital
    Shinjuku, Tokyo 160-8582, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03004599
Lead sponsor
Medico's Hirata Inc.
Responsible party
Sponsor
First posted
Dec 29, 2016
Start date
Nov 2016
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Nov 6, 2017
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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