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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: Transcatheter aortic valve replacement

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik Forschungsgesellschaft mbH
  • Dortmund, Germany
    • Johannes Hospital
  • Halle (Saale), Germany, 06120
    • Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie
  • Hamburg, Germany, 20246
    • Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • München, Germany, 80636
    • Deutsches Herzzentrum München
  • Regensburg, Germany, 93053
    • Universitätsklinik Regensburg
• Switzerland
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACURATE neo AS	Device: Transcatheter aortic valve replacement; Transcatheter aortic valve replacement via transfemoral access; Other Names: ACURATE neo™ AS Aortic Bioprosthesis (Commercial name: ACURATE neo2™ Aortic Valve); ACURATE neo™ AS TF Transfemoral Delivery System (Commercial name: ACURATE neo2™ Transfemoral Delivery System)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of all-cause mortality at 30 days follow-up	30 days post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
VARC Composite Safety at 30 days		30 days
Clinical improvement from baseline as per NYHA Functional Classification		7 days, 30 days, 12 months post-implant
Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient		7 days, 30 days, 12 months
Total aortic regurgitation		7 days, 30 days, 12 months

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Helge Möllmann, Prof., Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2016
• Primary Completion (Actual): January 24, 2018
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; TAVI; Transfemoral access; Transcatheter Aortic Valve Implant
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No