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

NCT03004599 | Terminated

• 1 other identifier: MH-P-002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Survival rate

  at 12 months post-procedure

Secondary Outcomes (16)

• Occurrence rates of MACCE

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

• Occurrence rates of individual MACCE components

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

• Occurrence rates of Major Adverse Events (MAEs)

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

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

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

• Change in NYHA class from baseline

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

Study Arms (1)

Transcatheter Aortic Valve Implantation (TAVI)

OTHER

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

Interventions

SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System DEVICE

Transcatheter Aortic Valve Implantation via Transfemoral Approach

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

Transcatheter Aortic Valve Implantation (TAVI)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Medico's Hirata Inc.: lead

Study Sites (5)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Sakakibara Heart Institute

Fuchū, Tokyo, 183-0003, Japan

Location

Keio University Hospital

Shinjuku, Tokyo, 160-8582, Japan

Location

Teikyo University Hospital

tabashi City, Tokyo, 173-8606, Japan

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 29, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

JP (5)