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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950428
• Other study ID #: 2015-01
• Status: Completed
• Phase: N/A
• Start date: November 18, 2015
• Est. completion date: September 3, 2021

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 3, 2021
• Est. primary completion date: April 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik	Bad Nauheim
Germany	Krankenhausbetriebsgesellschaft	Bad Oeynhausen
Germany	Deutsched Herzzentrum Berlin	Berlin
Germany	Martin Luther University Halle Winttenberg	Halle (Saale)
Germany	Universitätklinikum Hamburg Eppendorf	Hamburg
Germany	Herzentrum Leipzig GmbH	Leipzig
Germany	University Hospital Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety: freedom from all-cause mortality	freedom from all-cause mortality	6 months post procedure
Primary	Primary Device Performance:Procedure success in absence of MACCE	Procedure success in absence of MACCE	30 days post procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of device success	Rate of device success	7 days/ Discharge, 30 Days, 6 Months and at 12 Months
Secondary	NYHA Functional Classification improvement	NYHA Functional Classification improvement	30 Days, 6 Month and at 12 Months
Secondary	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