ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis

ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE Neo™ TA Transapical Delivery System in Patients With Severe Aortic Stenosis

The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: ACURATE neo™TA Delivery System

Detailed Description

This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention.

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik
  • Bad Oeynhausen, Germany, 32545
    • Krankenhausbetriebsgesellschaft
  • Berlin, Germany, 13353
    • Deutsched Herzzentrum Berlin
  • Halle (Saale), Germany, 06112
    • Martin Luther University Halle Winttenberg
  • Hamburg, Germany, 20246
    • Universitätklinikum Hamburg Eppendorf
  • Leipzig, Germany, 04289
    • Herzentrum Leipzig GmbH
  • Regensburg, Germany, 93053
    • University Hospital Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject must be at least 18 years old

2. Severe aortic stenosis defined as:

   • Mean aortic gradient > 40 mmHg or
   • Peak jet velocity > 4.0 m/s or
   • Aortic valve area of < 0.8 cm2
3. High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum
4. NYHA Functional Class > II

5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions:

   • porcelain aorta or
   • severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or
   • vessels too small for retrograde approach or
   • other anatomical conditions making transapical approach more suitable
6. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE
7. Patient willing to participate in the study and provides signed informed consent

Exclusion Criteria:

1. Congenital unicuspid or bicuspid aortic valve or non-calcified
2. Extreme eccentricity of calcification
3. Severe mitral regurgitation (> Grade 3)
4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
5. LV apex is not accessible via transapical access due to severe chest deformity
6. Previous surgery of the LV using a patch, such as the Dor procedure
7. Presence of apical LV thrombus
8. Calcified pericardium
9. Septal hypertrophy unacceptable for transapical procedure
10. Transesophageal echocardiogram (TEE) is contraindicated
11. ECHO evidence of intracardiac mass, thrombus, or vegetation
12. LVEF < 20% by ECHO
13. Need for emergency intervention for any reason within 30 Days of scheduled procedure
14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
15. Untreated clinically significant coronary artery disease requiring revascularization within 30 days before or after the study procedure
16. Acute myocardial infarction within 1 month prior to implant procedure
17. Previous TIA or stroke within 6 months prior to implant procedure
18. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure
19. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
20. History of bleeding diathesis, coagulopathy, refusal of blood transfusions or severe anemia (Hb<8 g/dL)
21. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
22. Primary hypertrophic obstructive cardiomyopathy (HOCM)
23. Active infection or endocarditis
24. Hepatic failure (> Child B)
25. Chronic renal dysfunction with serum creatinine > 3.0 mg/dL or renal dialysis
26. Neurological disease severely affecting ambulation, daily functioning, or dementia
27. Life expectancy < 12 months due to non-cardiac co-morbid conditions
28. Intolerance to aspirin, clopidogrel, contrast media, or porcine tissue and allergy to nickel
29. Pregnant or breast-feeding women
30. For other severe illnesses of the patient (e.g. active carcinoma), the investigator shall decide on an individual basis whether the patient is not to be included in the study
31. Currently participating in an investigational drug or another device study

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™TA Delivery System; Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System	Device: ACURATE neo™TA Delivery System; ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety: freedom from all-cause mortality	freedom from all-cause mortality	6 months post procedure
Primary Device Performance:Procedure success in absence of MACCE	Procedure success in absence of MACCE	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines	VARC 2 guidelines include different safety and efficacy endpoints like mortality, MI, stroke, etc.	30 Days and month 12
Incidence of all cause mortality at 30 Days and 12 Months	Incidence of all cause mortality at 30 Days and 12 Months	30 days and 12 months
Freedom from MACCE at 30 Days, 6 Months and 12 Months	Freedom from MACCE at 30 Days, 6 Months and 12 Months	30 Days, 6 Months and 12 Months
Number of patients who have a Procedural success defined by a combination of criteria	Procedural success defined as ACURATE neo™ at intended location with	procedure
Rate of device success	Rate of device success	7 days/ Discharge, 30 Days, 6 Months and at 12 Months
NYHA Functional Classification improvement	NYHA Functional Classification improvement	30 Days, 6 Month and at 12 Months
Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures	Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures	7 Days or Discharge, 30 Days, 6 Months, 12 Months

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Markus Pr Schönburg, Prof.Dr.Med, Abteilung Herzchirurgie Kerckhoff-Klinik

Publications and helpful links

General Publications

• Conradi L, Hilker M, Kempfert J, Borgermann J, Treede H, Holzhey DM, Schrofel H, Kim WK, Schaefer U, Walther T. Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes. Eur J Cardiothorac Surg. 2018 Oct 1;54(4):762-767. doi: 10.1093/ejcts/ezy097.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2015
• Primary Completion (Actual): April 17, 2017
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Aortic Stenosis; TAVI; transcatether Aortic Valve Implantation
• 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: 2015-01

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