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ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

Primary Purpose

Symptomatic Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ACURATE TF™
Sponsored by
Symetis SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Aortic Stenosis focused on measuring Severe Symptomatic Aortic Valve Stenosis

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients 75 years of age and older
  2. Logistic EuroSCORE ≥ 20%
  3. Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area of < 1.0 cm2
  4. New York Heart Association (NYHA) Functional Class > II
  5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE)
  6. Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis
  7. Patient willing to participate in the study and provide signed informed consent

Exclusion Criteria:

  1. Unicuspid or bicuspid aortic valve
  2. Extreme eccentricity of calcification
  3. Severe mitral regurgitation ( >2+)
  4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
  5. Aortic or peripheral anatomy NOT appropriate for transfemoral implant
  6. Thoracic (TAA) or abdominal (AAA) aortic aneurysm
  7. Presence of endovascular stent graft for treatment of TAA or AAA
  8. TEE is contraindicated
  9. Left Ventricular Ejection Fraction (LVEF) < 30% by echocardiography (ECHO)
  10. ECHO evidence of intracardiac mass, thrombus, or vegetation
  11. Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure
  12. Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
  13. Previous Transien Ischemic Attack (TIA) or stroke within 3 months prior to implant procedure
  14. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
  15. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
  16. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  17. Systolic pressure <80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP)
  18. Primary hypertrophic obstructive cardiomyopathy (HOCM)
  19. Active infection, endocarditis or pyrexia
  20. Hepatic failure
  21. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
  22. Refusal of surgery
  23. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
  24. Neurological disease severely affecting ambulation or daily functioning, or dementia
  25. Life expectancy < 12 months due to non-cardiac co-morbid conditions
  26. Known hypersensitivity/contraindication to study medication, contrast media, or nitinol
  27. Currently participating in an investigational drug or another device study

Sites / Locations

  • Instituto Dante Pazzanese de Cardiologia
  • Kerckhoff Klinik GmbH
  • Universitätsklinikum Bonn
  • Universitäres Herzzentrum Hamburg
  • Herzzentrum Universitätsklinikum Köln
  • Osaka University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Symetis ACURATE TF™

Arm Description

Patient implanted with ACURATE TF™Bioprosthesis.

Outcomes

Primary Outcome Measures

Freedom from all-cause mortality
Rate of all-cause mortality

Secondary Outcome Measures

Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke.
Change in NYHA class over time
Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.
Procedural success during device implantation
Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality.
Device success
Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography. The following data points will be analyzed for adequate functioning of the study device: Effective orifice area and index (EOA) Peak jet velocity Transvalvular aortic gradient (mean) Paravalvular and intravalvular (central) leak Aortic Insufficiency Valve function and morphology

Full Information

First Posted
December 2, 2016
Last Updated
November 22, 2018
Sponsor
Symetis SA
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1. Study Identification

Unique Protocol Identification Number
NCT03003650
Brief Title
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort
Official Title
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts
Detailed Description
A prospective, multicenter, "CE-approval cohort" analysis with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Aortic Stenosis
Keywords
Severe Symptomatic Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symetis ACURATE TF™
Arm Type
Experimental
Arm Description
Patient implanted with ACURATE TF™Bioprosthesis.
Intervention Type
Device
Intervention Name(s)
ACURATE TF™
Other Intervention Name(s)
ACURATE TF™Transfemoral Aortic Bioprosthesis and Delivery System
Intervention Description
ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .
Primary Outcome Measure Information:
Title
Freedom from all-cause mortality
Description
Rate of all-cause mortality
Time Frame
30-Day Follow-up
Secondary Outcome Measure Information:
Title
Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.
Description
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke.
Time Frame
30-Days and 12 Months Follow-up
Title
Change in NYHA class over time
Description
Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.
Time Frame
30-Day and 12-Month
Title
Procedural success during device implantation
Description
Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality.
Time Frame
intraoperative
Title
Device success
Description
Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography. The following data points will be analyzed for adequate functioning of the study device: Effective orifice area and index (EOA) Peak jet velocity Transvalvular aortic gradient (mean) Paravalvular and intravalvular (central) leak Aortic Insufficiency Valve function and morphology
Time Frame
30-Day and 12-Month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 75 years of age and older Logistic EuroSCORE ≥ 20% Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area of < 1.0 cm2 New York Heart Association (NYHA) Functional Class > II Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE) Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis Patient willing to participate in the study and provide signed informed consent Exclusion Criteria: Unicuspid or bicuspid aortic valve Extreme eccentricity of calcification Severe mitral regurgitation ( >2+) Pre-existing prosthetic heart valve in any position and / or prosthetic ring Aortic or peripheral anatomy NOT appropriate for transfemoral implant Thoracic (TAA) or abdominal (AAA) aortic aneurysm Presence of endovascular stent graft for treatment of TAA or AAA TEE is contraindicated Left Ventricular Ejection Fraction (LVEF) < 30% by echocardiography (ECHO) ECHO evidence of intracardiac mass, thrombus, or vegetation Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure Previous Transien Ischemic Attack (TIA) or stroke within 3 months prior to implant procedure Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure Any 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 <80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP) Primary hypertrophic obstructive cardiomyopathy (HOCM) Active infection, endocarditis or pyrexia Hepatic failure Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis Refusal of surgery Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen Neurological disease severely affecting ambulation or daily functioning, or dementia Life expectancy < 12 months due to non-cardiac co-morbid conditions Known hypersensitivity/contraindication to study medication, contrast media, or nitinol Currently participating in an investigational drug or another device study
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
CEP 04012-909
Country
Brazil
Facility Name
Kerckhoff Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Herzzentrum Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan

12. IPD Sharing Statement

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ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

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