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

Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis Symptomatic
• Intervention / Treatment: Device: ACURATE TA™

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik GmbH
  • Essen, Germany, 45122
    • Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
  • Freiburg, Germany
    • Universitätsklinikum Freiburg Herz- und Gefäßchirurgie
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint	Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance endpoint	Stable ACURATE placement at intended site as assessed by angiography	Up to 24-hours post-procedure
Performance endpoint	Adequate ACURATE device function as assessed by echocardiography	Up to 24-hours post-procedure
Mortality	Freedom from Death at follow-up	30 days, 60 days, 3 months, 6 months and 12 months
MAVRE at follow-up	Rate of MAVRE at follow-up	discharge or 7 days, 3 months, 6 months and 12 months
MACCE or Major Adverse Cardiac and Cerebrovascular Event	Rate of MACCE at follow up	1 month, 3 months, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Friedrich Mohr, Professor, Herzzentrum Leipzig GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Severe Symptomatic Aortic Valve Stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2009-01; DE/CA84/73-KL-30-09 (Other Identifier: Landesdirektion Sachsen - Freistaat Sachsen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO