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

NCT ID: NCT02950428

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-18
• Study Completion Date: 2021-09-03

Brief 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.

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: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACURATE neo™TA Delivery System

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

Group Type: EXPERIMENTAL

ACURATE neo™TA Delivery System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symetis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Pr Schönburg, Prof.Dr.Med

Role: PRINCIPAL_INVESTIGATOR

Abteilung Herzchirurgie Kerckhoff-Klinik

Locations

Kerckhoff-Klinik

Bad Nauheim, , Germany

Krankenhausbetriebsgesellschaft

Bad Oeynhausen, , Germany

Deutsched Herzzentrum Berlin

Berlin, , Germany

Martin Luther University Halle Winttenberg

Halle, , Germany

Universitätklinikum Hamburg Eppendorf

Hamburg, , Germany

Herzentrum Leipzig GmbH

Leipzig, , Germany

University Hospital Regensburg

Regensburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29554265 (View on PubMed)

Other Identifiers

2015-01

Identifier Type: -

Identifier Source: org_study_id