ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

Symptomatic Aortic Stenosis Clinical Trial

Official title:

ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003650
• Other study ID #: TF89
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: August 2017

Study information

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

Clinical Trial Summary

First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts

Description:

A prospective, multicenter, "CE-approval cohort" analysis 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, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2017
• Est. primary completion date: July 2013
• 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 of < 1.0 cm2

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

5. Aortic annulus diameter from = 21mm up to = 27mm by Trans-esophageal Echocardiography (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. TEE is contraindicated

9. Left Ventricular 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 Transien 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 Obstructive 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 Valve Stenosis
• Constriction, Pathologic
• Symptomatic Aortic Stenosis

Intervention

Device:
• ACURATE TF™
ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .

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
Japan	Osaka University Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Countries where clinical trial is conducted

Brazil,  Germany,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from all-cause mortality	Rate of all-cause mortality	30-Day Follow-up
Secondary	Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.	Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke.	30-Days and 12 Months Follow-up
Secondary	Change in NYHA class over time	Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.	30-Day and 12-Month
Secondary	Procedural success during device implantation	Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality.	intraoperative
Secondary	Device success	Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography.; The following data points will be analyzed for adequate functioning of the study device: Effective orifice area and index (EOA); Peak jet velocity; Transvalvular aortic gradient (mean); Paravalvular and intravalvular (central) leak; Aortic Insufficiency; Valve function and morphology	30-Day and 12-Month Follow-up