ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)

NCT ID: NCT03752996

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-09
• Study Completion Date: 2022-03-30

Brief Summary

First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Detailed Description

A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk.

Conditions

Aortic Stenosis Symptomatic

Study Design

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

Study Groups

ACURATE TF™ Aortic Valve System

ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement .

Group Type: EXPERIMENTAL

ACURATE TF™ Aortic Valve System

Intervention Type: DEVICE

Transcatheter Aortic Valve Implantation

Interventions

ACURATE TF™ Aortic Valve System

Transcatheter Aortic Valve Implantation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients 75 years of age and older

2. Logistic EuroSCORE ≥ 20%

3. Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area < 1.0 cm2

4. New York Heart Association (NYHA) Functional Class > II

5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by TEE

6. Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis

7. Patient willing to participate in the study and provide signed informed consent

Exclusion Criteria

1. Unicuspid or bicuspid aortic valve

2. Extreme eccentricity of calcification

3. Severe mitral regurgitation ( >2+)

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

5. Aortic or peripheral anatomy NOT appropriate for transfemoral implant

6. Thoracic (TAA) or abdominal (AAA) aortic aneurysm

7. Presence of endovascular stent graft for treatment of TAA or AAA

8. Trans-esophageal echocardiogram (TEE) is contraindicated

9. Left Ventricle Ejection Fraction (LVEF) < 30% by echocardiography (ECHO)

10. ECHO evidence of intracardiac mass, thrombus, or vegetation

11. Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure

12. Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure

13. Previous Transient Ischemic Attack (TIA) or stroke within 3 months prior to implant procedure

14. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure

15. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit

16. History of bleeding diathesis or coagulopathy or refusal of blood transfusions

17. Systolic pressure <80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP)

18. Primary hypertrophic obstructive cardiomyopathy (HOCM)

19. Active infection, endocarditis or pyrexia

20. Hepatic failure

21. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis

22. Refusal of surgery

23. Severe Chronic Obstruction Pulmonary Disease (COPD) requiring home oxygen

24. Neurological disease severely affecting ambulation or daily functioning, or dementia

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

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

27. 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

Won Keun Kim, Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Klinik Bad Nauheim, Germany

Locations

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Kerckhoff Klinik GmbH

Bad Nauheim, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Herzzentrum Universitätsklinikum Köln

Cologne, , Germany

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Countries

Brazil; Germany

Other Identifiers

2011-03

Identifier Type: -

Identifier Source: org_study_id