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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909556
• Other study ID #: 2016-01
• Status: Completed
• Phase: N/A
• Start date: December 16, 2016
• Est. completion date: January 13, 2023

Study information

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

Clinical Trial Summary

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 13, 2023
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via transfemoral access

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Germany	Kerckhoff-Klinik Forschungsgesellschaft mbH	Bad Nauheim
Germany	Johannes Hospital	Dortmund
Germany	Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie	Halle (Saale)
Germany	Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie	Hamburg
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Deutsches Herzzentrum München	München
Germany	Universitätsklinik Regensburg	Regensburg
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Countries where clinical trial is conducted

Denmark,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause mortality at 30 days follow-up		30 days post-implant
Secondary	Rate of clinical events as defined per VARC guidelines	Clinical events: Mortality; Stroke; Myocardial infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications	7 days, 30 days, 12 months post-implant
Secondary	Procedural success	2. Procedural success defined as absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one aortic bioprosthesis (valve in valve); or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication	Day of implant
Secondary	Device success	3. Device success defined as: Absence of intra-procedure mortality AND,; Correct positioning of a single prosthetic heart valve into the proper anatomical location AND,; Intended performance of the prosthetic heart valve (EOAi >0.85 cm2/m2 and mean aortic valve gradient <20mmHg without moderate or severe AR)	Day of implant
Secondary	VARC Composite Safety at 30 days		30 days
Secondary	Clinical improvement from baseline as per NYHA Functional Classification		7 days, 30 days, 12 months post-implant
Secondary	Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient		7 days, 30 days, 12 months
Secondary	Total aortic regurgitation		7 days, 30 days, 12 months