Clincosm LogoSign in Get a demo

TA-FIM: Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)

Sponsor
Symetis SA (Industry)
Overall Status
Completed
CT.gov ID
NCT03567278
Collaborator
(none)
40
Enrollment
5
Locations
1
Arm
70
Duration (Months)
8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Condition or Disease Intervention/Treatment Phase
  • Device: ACURATE TA™
 N/A

Detailed Description

A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating the feasibility and performance of the implantation and the safety at 30-Day follow-up.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Medical Device StudyMedical Device Study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACURATE TA™

Patients implanted with ACURATE TA™ Bioprosthesis

Device: ACURATE TA™
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement surgery.
Other Names:
  • ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety endpoint [30 days]

      Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE

    Secondary Outcome Measures

    1. Performance endpoint [Up to 24-hours post-procedure]

      Stable ACURATE placement at intended site as assessed by angiography

    2. Performance endpoint [Up to 24-hours post-procedure]

      Adequate ACURATE device function as assessed by echocardiography

    3. Mortality [30 days, 60 days, 3 months, 6 months and 12 months]

      Freedom from Death at follow-up

    4. MAVRE at follow-up [discharge or 7 days, 3 months, 6 months and 12 months]

      Rate of MAVRE at follow-up

    5. MACCE or Major Adverse Cardiac and Cerebrovascular Event [1 month, 3 months, 6 months and 12 months]

      Rate of MACCE at follow up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients older than 75 years;

    • Additive EuroSCORE > 9 and/or STS > 9%;

    • Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient > 40mmHg,and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²;

    • NYHA Functional Class > II;

    • Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography;

    • Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) [STJ>1.1xAAn] AND STJ<45mm by transoesophageal echocardiography;

    • Patient understands the implications of participating in the study and provides signed informed consent

    Exclusion Criteria:

    • Congenital unicuspid or bicuspid aortic valve;

    • Severe eccentricity of calcification;

    • Severe mitral regurgitation (> 2°);

    • Pre-existing prosthetic heart valve in any position and /or prosthetic ring;

    • Severe transapical access problem, non-reachable LV apex;

    • Previous surgery of the LV using a patch, such as the Dor procedure;

    • Presence of apical LV thrombus;

    • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;

    • Acute Myocardial Infarction (AMI) within 1 month prior to the procedure;

    • PCI within 1 month prior to the procedure;

    • Previous Transient Ischemic Accident (TIA) or stroke in the last 3 months;

    • Untreated clinically significant CAD requiring revascularization;

    • Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump;

    • Severe left ventricular dysfunction with a LV Ejection Fraction (LVEF) < 25% by echocardiography;

    • Calcified pericardium;

    • Septal hypertrophy;

    • Primary Hypertrophic Obstructive Cardiomyopathy (HOCM);

    • Active infection, endocarditis or pyrexia;

    • Active peptic ulcer or Gastrointestinal (GI) bleeding within the past 3 months;

    • Significant hepatic involvement (Child > B);

    • Major lung disease (FEV < 0.8 or FEV1% < 30% of normal);

    • Pulmonary hypertension;

    • History of bleeding diathesis or coagulopathy;

    • Hematologic disorder (WBC<3000mm3, Hb<9g/dL, platelet count <50000 cells/ mm3);

    • Serum creatinine level greater than 3.0 mg/dL or chronic renal failure requiring dialysis;

    • Neurological disease severely affecting ambulation or daily functioning, including dementia;

    • Other procedure scheduled at the same time, whether surgery or percutaneous approach;

    • Emergency procedure;

    • Life expectancy < 12 months due to non-cardiac co-morbid conditions;

    • Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol;

    • Currently participating in an investigational drug or another device study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kerckhoff Klinik GmbH Bad Nauheim Germany 61231
    2 Universitätsklinikum Essen Westdeutsches Herzzentrum Essen Essen Germany 45122
    3 Universitätsklinikum Freiburg Herz- und Gefäßchirurgie Freiburg Germany
    4 Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefäßchirurgie Hamburg Germany 20246
    5 Herzzentrum Leipzig GmbH Leipzig Germany 04289

    Sponsors and Collaborators

    • Symetis SA

    Investigators

    • Principal Investigator: Friedrich Mohr, Professor, Herzzentrum Leipzig GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Symetis SA
    ClinicalTrials.gov Identifier:
    NCT03567278
    Other Study ID Numbers:
    • 2009-01
    • DE/CA84/73-KL-30-09
    First Posted:
    Jun 25, 2018
    Last Update Posted:
    Jun 25, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Symetis SA
    Severe Symptomatic Aortic Valve Stenosis
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Jun 25, 2018