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

NCT ID: NCT02986737

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-08
• Study Completion Date: 2019-10-31

Brief 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

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.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

ACURATE neo™ and ACURATE TA™ LP

Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System

Group Type: EXPERIMENTAL

ACURATE neo™ and ACURATE TA™ LP

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symetis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirko Doss, Prof.Dr.Med

Role: PRINCIPAL_INVESTIGATOR

Abteilung Herzchirurgie Kerckhoff-Klinik

Locations

Kerckhoff-Klinik

Bad Nauheim, , Germany

Klinik für Herz-und Gefäßchirurgie

Hamburg, , Germany

Countries

Germany

Other Identifiers

2014-02

Identifier Type: -

Identifier Source: org_study_id