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ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03) (2011-03)

Primary Purpose

Aortic Stenosis Symptomatic

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

About this trial

This is an interventional treatment trial for Aortic Stenosis Symptomatic

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 < 1.0 cm2
  4. New York Heart Association (NYHA) Functional Class > II
  5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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. Trans-esophageal echocardiogram (TEE) is contraindicated
  9. Left Ventricle 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 Transient 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 Obstruction 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACURATE TF™ Aortic Valve System

Arm Description

ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement .

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)
Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke

Full Information

First Posted
November 21, 2018
Last Updated
February 22, 2023
Sponsor
Symetis SA
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1. Study Identification

Unique Protocol Identification Number
NCT03752996
Brief Title
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
Acronym
2011-03
Official Title
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2012 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
March 30, 2022 (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
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
Detailed Description
A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ACURATE TF™ Aortic Valve System
Arm Type
Experimental
Arm Description
ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement .
Intervention Type
Device
Intervention Name(s)
ACURATE TF™ Aortic Valve System
Intervention Description
Transcatheter Aortic Valve Implantation
Primary Outcome Measure Information:
Title
Freedom from all-cause mortality
Description
Rate of all-cause mortality
Time Frame
30-Days
Secondary Outcome Measure Information:
Title
Rate of MACCE (major cardiac and cerebrovascular event)
Description
Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke
Time Frame
30-Days and 12-Months

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 < 1.0 cm2 New York Heart Association (NYHA) Functional Class > II Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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 Trans-esophageal echocardiogram (TEE) is contraindicated Left Ventricle 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 Transient 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 Obstruction 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Keun Kim, Dr. Med.
Organizational Affiliation
Kerckhoff Klinik Bad Nauheim, Germany
Official's Role
Principal Investigator
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)

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