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

Aortic Stenosis Clinical Trial

— TALP-FIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986737
• Other study ID #: 2014-02
• Status: Completed
• Phase: N/A
• Start date: December 8, 2014
• Est. completion date: October 2019

Study information

• Verified date: April 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device

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: 15
• Est. completion date: October 2019
• Est. primary completion date: March 3, 2015
• 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 > 40mmHg or o Peak jet velocity > 4.0m/sor Aortic valve area of < 1.0cm2

3. High risk candidate for conventional AVR defined as:

STS score = 10 or Multidisciplinary 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. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route

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

2. Extreme eccentricity of calcification

3. Severe mitral regurgitation (> Grade 2)

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 < 30% by ECHO

13. Emergency procedure pre-implant including CAD requiring revascularization

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 gastrointestinal (GI) bleeding within 3 months prior to implant procedure

18. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit

19. History of bleeding diathesis or coagulopathy or refusal of blood transfusions

20. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP

21. Primary hypertrophic obstructive cardiomyopathy (HOCM)

22. Active infection, endocarditis or pyrexia

23. Hepatic failure (> Child B)

24. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis

25. Refusal of surgery

26. Severe COPD requiring home oxygen

27. Neurological disease severely affecting ambulation, daily functioning, or dementia

28. Life expectancy < 12 months due to non-cardiac co-morbid conditions

29. Contraindication to study medication, contrast media, or allergy to nitinol

30. 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™ and ACURATE TA™ LP
ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP 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	Klinik für Herz-und Gefäßchirurgie	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	incidence of all cause mortality at 30 days	30 days
Primary	Mean aortic gradient after device implantation	mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up	7 days or Discharge
Secondary	rate of clinical endpoints VARC II	rate of clinical endpoints VARC II at 30 days and 12 months	30 days and month 12
Secondary	procedural success	procedural success defined as ACURATE neo™ at intended location	procedure
Secondary	device success assessed according to composite VARC 2 criteria	Device success defined as: ACURATE neo™ implanted in intended location; No impingement of the mitral valve; Normal coronary blood flow; Insufficiency < Grade 3; Mean aortic gradient < 20mmHg; EOA = 1.0 cm2 No further re-intervention performed on the ACURATE neo™ implant	7 days, 30 days, 12 months
Secondary	functional improvement from Baseline as per NYHA Functional Classification	functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up	30 days and 12 months follow up