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

Aortic Stenosis Symptomatic Clinical Trial

— TA-FIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567278
• Other study ID #: 2009-01
• Secondary ID: DE/CA84/73-KL-30
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: September 2015

Study information

• Verified date: May 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis Symptomatic
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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.

Locations

Country	Name	City	State
Germany	Kerckhoff Klinik GmbH	Bad Nauheim
Germany	Universitätsklinikum Essen Westdeutsches Herzzentrum Essen	Essen
Germany	Universitätsklinikum Freiburg Herz- und Gefäßchirurgie	Freiburg
Germany	Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefäßchirurgie	Hamburg
Germany	Herzzentrum Leipzig GmbH	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoint	Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE	30 days
Secondary	Performance endpoint	Stable ACURATE placement at intended site as assessed by angiography	Up to 24-hours post-procedure
Secondary	Performance endpoint	Adequate ACURATE device function as assessed by echocardiography	Up to 24-hours post-procedure
Secondary	Mortality	Freedom from Death at follow-up	30 days, 60 days, 3 months, 6 months and 12 months
Secondary	MAVRE at follow-up	Rate of MAVRE at follow-up	discharge or 7 days, 3 months, 6 months and 12 months
Secondary	MACCE or Major Adverse Cardiac and Cerebrovascular Event	Rate of MACCE at follow up	1 month, 3 months, 6 months and 12 months