ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis (TALP-FIM)

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

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: ACURATE neo™ and ACURATE TA™ LP

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): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik
  • Hamburg, Germany, 20246
    • Klinik für Herz-und Gefäßchirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 71 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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™ and ACURATE TA™ LP; Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	incidence of all cause mortality at 30 days	30 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of clinical endpoints VARC II	rate of clinical endpoints VARC II at 30 days and 12 months	30 days and month 12
procedural success	procedural success defined as ACURATE neo™ at intended location	procedure
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
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

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Mirko Doss, Prof.Dr.Med, Abteilung Herzchirurgie Kerckhoff-Klinik

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2014
• Primary Completion (Actual): March 3, 2015
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

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: 2014-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No