Clinical trial NCT02909556: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: Transcatheter Aortic Valve Replacement
TAVI
Transcatheter Aortic Valve Implant
Transfemoral access
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Rate of all-cause mortality at 30 days follow-up
timeFrame: 30 days post-implant
Secondary outcomes:
measure: Rate of clinical events as defined per VARC guidelines
timeFrame: 7 days, 30 days, 12 months post-implant
measure: Procedural success
timeFrame: Day of implant
measure: Device success
timeFrame: Day of implant
measure: VARC Composite Safety at 30 days
timeFrame: 30 days
measure: Clinical improvement from baseline as per NYHA Functional Classification
timeFrame: 7 days, 30 days, 12 months post-implant
measure: Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient
timeFrame: 7 days, 30 days, 12 months
measure: Total aortic regurgitation
timeFrame: 7 days, 30 days, 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik Forschungsgesellschaft mbH
city: Dortmund
country: Germany
facility: Johannes Hospital
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Regensburg
country: Germany
facility: Universitätsklinik Regensburg
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany
name: Helge Möllmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References: