ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Brief Title

ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Official Title

ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Brief Summary

      Cinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic
      Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval
      purposes.

Detailed Description

      Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this
      trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic
      Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System

      The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System
      are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR)
      using transfemoral access in patients presenting with severe aortic valve stenosis.

      The primary objective is to evaluate the safety and performance of the study device in
      patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.

      The secondary objective is to evaluate adverse events and study device performance.

Study Type

Interventional

Primary Outcome

Rate of all-cause mortality at 30 days follow-up

Secondary Outcome

 Rate of clinical events as defined per VARC guidelines

Condition

Aortic Stenosis

Intervention

Transcatheter aortic valve replacement

Study Arms / Comparison Groups

 ACURATE neo AS

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

December 16, 2016

Completion Date

February 2023

Primary Completion Date

January 24, 2018

Eligibility Criteria

Inclusion Criteria:

1. Patient 75 years of age and older

2. Severe aortic stenosis defined as:

- Mean aortic gradient > 40 mmHg or

- Peak jet velocity > 4.0 m/s or

- Aortic valve area of < 1.0 cm2

3. High risk candidate for conventional AVR defined as:

- Logistic EuroSCORE 1 ≥ 20% or

- STS Score ≥ 8% or

- Heart team (cardiologist and cardiac surgeon) consensus that patient is not a
surgical candidate for conventional AVR due to significant co-morbid conditions
unrelated to aortic stenosis

4. NYHA Functional Class > II

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

6. Patient willing to participate in the study and provides signed informed consent

Exclusion Criteria:

1. Congenital aortic stenosis or unicuspid or bicuspid aortic valve

2. Non-stenotic Aortic Insufficiency

3. Severe eccentricity of calcification

4. Severe mitral regurgitation (>2+)

5. Presence of mitral bioprosthesis

6. Presence of previously implanted aortic bioprosthesis

7. Presence of prosthetic ring

8. Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree
of calcification or tortuosity of the aorta or ilio-femoral arteries

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

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

11. Trans-oesophageal echocardiogram (TEE) is contraindicated

12. Evidence of intra-cardiac mass, thrombus or vegetation

13. Severe ventricular dysfunction with ejection fraction < 20%

14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month
prior to implant procedure

15. Acute Myocardial Infarction within 1 month prior to implant procedure

16. Previous TIA or stroke within 3 months prior to implant procedure

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

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

19. Severe coagulation conditions

20. Refusal of blood transfusions

21. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP

22. Hypertrophic cardiomyopathy with or without obstruction

23. Active bacterial endocarditis or other active infections

24. Hepatic failure (> Child B)

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

26. Refusal of surgery

27. Severe COPD requiring home oxygen

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

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

30. Inability to tolerate anticoagulation therapy

31. Contraindication to contrast media or allergy to nickel

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

33. Non-valvular aortic stenosis

34. Non-calcific acquired aortic stenosis

Gender

All

Ages

75 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Helge Möllmann, Prof., ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT02909556

Organization ID

2016-01

Responsible Party

Sponsor

Study Sponsor

Symetis SA

Study Sponsor

Helge Möllmann, Prof., Principal Investigator, Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany

Verification Date

March 2020