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

Aortic Stenosis Symptomatic Clinical Trial

— 2011-03  

Official title:

ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752996
• Other study ID #: 2011-03
• Status: Completed
• Phase: N/A
• Start date: May 9, 2012
• Est. completion date: March 30, 2022

Study information

• Verified date: February 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 30, 2022
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• ACURATE TF™ Aortic Valve System
Transcatheter Aortic Valve Implantation

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Germany	Kerckhoff Klinik GmbH	Bad Nauheim
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Herzzentrum Universita¨tsklinikum Ko¨ln	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Countries where clinical trial is conducted

Brazil,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from all-cause mortality	Rate of all-cause mortality	30-Days
Secondary	Rate of MACCE (major cardiac and cerebrovascular event)	Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke	30-Days and 12-Months