ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)

NCT ID: NCT03143673

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-07-31

Brief Summary

The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.

Detailed Description

A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie 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 safety and performance of the implantation and safety at 30-D follow-up.

Conditions

Aortic Symptomatic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACURATE TA™

Patient implanted with ACURATE TA™ Bioprosthesis

Group Type: EXPERIMENTAL

ACURATE TA™

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System

Eligibility Criteria

Inclusion Criteria

1. Patients at least 75 years of age

2. Additive EuroSCORE > 9

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

4. NYHA Functional Class > II

5. Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)

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

Exclusion Criteria

1. Congenital unicuspid or bicuspid aortic valve

2. Severe eccentricity of calcification

3. Severe mitral regurgitation (> 2°)

4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring

5. Severe transapical access problem, non-reachable LV apex

6. Previous surgery of the LV using a patch, such as the Dor procedure

7. Presence of apical LV thrombus

8. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

9. Acute myocardial infarction (AMI) within 1 month prior to the procedure

10. PCI within 1 month prior to the procedure

11. Previous transient ischemic attack (TIA) or stroke in the last 3 months

12. Untreated clinically significant coronary artery disease (CAD) requiring revascularization

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

14. Severe left ventricular dysfunction (LVEF) < 30% by echocardiography

15. Calcified pericardium

16. Septal hypertrophy unacceptable for transapical procedure

17. Primary hypertrophic obstructive cardiomyopathy (HOCM)

18. Active infection, endocarditis or pyrexia

19. Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months

20. Significant hepatic involvement (Child > B)

21. Severe COPD requiring home oxygen

22. History of bleeding diathesis or coagulopathy

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

24. Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis

25. Neurological disease severely affecting ambulation or daily functioning, including dementia

26. Another surgical or percutaneous procedure scheduled at the same time

27. Emergency procedure

28. Life expectancy < 12 months due to non-cardiac co-morbid conditions

29. Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol

30. Currently participating in an investigational drug or another device study

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symetis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Walther, Professor

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Klinik

Locations

Kerckhoff Klinik GmbH

Bad Nauheim, , Germany

Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie

Essen, , Germany

Universitätsklinikum Essen Westdeutsches Herzzentrum Essen

Essen, , Germany

Klinik für Herzchirurgie GmbH

Karlsruhe, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Countries

Germany

Other Identifiers

95.02-5660-6278

Identifier Type: OTHER

Identifier Source: secondary_id

2010-01

Identifier Type: -

Identifier Source: org_study_id