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

Primary Purpose

Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ACURATE neo™ and ACURATE TA™ LP
Sponsored by
Symetis SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Aortic Stenosis focused on measuring TAVI, Aortic Stenosis, Transcatether Aortic Valve Implantation

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kerckhoff-Klinik
  • Klinik für Herz-und Gefäßchirurgie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACURATE neo™ and ACURATE TA™ LP

Arm Description

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

Outcomes

Primary Outcome Measures

All cause mortality
incidence of all cause mortality at 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

Secondary Outcome Measures

rate of clinical endpoints VARC II
rate of clinical endpoints VARC II at 30 days and 12 months
procedural success
procedural success defined as ACURATE neo™ at intended location
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
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

Full Information

First Posted
December 6, 2016
Last Updated
April 7, 2020
Sponsor
Symetis SA
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1. Study Identification

Unique Protocol Identification Number
NCT02986737
Brief Title
ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
Acronym
TALP-FIM
Official Title
ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 8, 2014 (Actual)
Primary Completion Date
March 3, 2015 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symetis SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
TAVI, Aortic Stenosis, Transcatether Aortic Valve Implantation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Medical device trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACURATE neo™ and ACURATE TA™ LP
Arm Type
Experimental
Arm Description
Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System
Intervention Type
Device
Intervention Name(s)
ACURATE neo™ and ACURATE TA™ LP
Intervention Description
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
Primary Outcome Measure Information:
Title
All cause mortality
Description
incidence of all cause mortality at 30 days
Time Frame
30 days
Title
Mean aortic gradient after device implantation
Description
mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up
Time Frame
7 days or Discharge
Secondary Outcome Measure Information:
Title
rate of clinical endpoints VARC II
Description
rate of clinical endpoints VARC II at 30 days and 12 months
Time Frame
30 days and month 12
Title
procedural success
Description
procedural success defined as ACURATE neo™ at intended location
Time Frame
procedure
Title
device success assessed according to composite VARC 2 criteria
Description
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
Time Frame
7 days, 30 days, 12 months
Title
functional improvement from Baseline as per NYHA Functional Classification
Description
functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up
Time Frame
30 days and 12 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient 75 years of age and older Severe aortic stenosis defined as: Mean aortic gradient > 40mmHg or o Peak jet velocity > 4.0m/sor Aortic valve area of < 1.0cm2 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 NYHA Functional Class > II Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE Patient willing to participate in the study and provides signed informed consent Exclusion Criteria: Congenital unicuspid or bicuspid aortic valve Extreme eccentricity of calcification Severe mitral regurgitation (> Grade 2) Pre-existing prosthetic heart valve in any position and / or prosthetic ring LV apex is not accessible via transapical access due to severe chest deformity Previous surgery of the LV using a patch, such as the Dor procedure Presence of apical LV thrombus Calcified pericardium Septal hypertrophy unacceptable for transapical procedure Transesophageal echocardiogram (TEE) is contraindicated ECHO evidence of intracardiac mass, thrombus, or vegetation LVEF < 30% by ECHO Emergency procedure pre-implant including CAD requiring revascularization Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure Acute myocardial infarction within 1 month prior to implant procedure Previous TIA or stroke within 3 months prior to implant procedure Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit History of bleeding diathesis or coagulopathy or refusal of blood transfusions Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP Primary hypertrophic obstructive cardiomyopathy (HOCM) Active infection, endocarditis or pyrexia Hepatic failure (> Child B) Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis Refusal of surgery Severe COPD requiring home oxygen Neurological disease severely affecting ambulation, daily functioning, or dementia Life expectancy < 12 months due to non-cardiac co-morbid conditions Contraindication to study medication, contrast media, or allergy to nitinol Currently participating in an investigational drug or another device study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirko Doss, Prof.Dr.Med
Organizational Affiliation
Abteilung Herzchirurgie Kerckhoff-Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Klinik für Herz-und Gefäßchirurgie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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