Back to resultsACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01) (TA-PILOT)
Primary Purpose
Aortic Symptomatic Stenosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ACURATE TA™
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Symptomatic Stenosis focused on measuring Severe Symptomatic Aortic Valve Stenosis
Eligibility Criteria
Inclusion Criteria:
- Patients at least 75 years of age
- Additive EuroSCORE > 9
- Severe AS assessed by echocardiography and documented by a mean gradient > 40mmHg and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²
- NYHA Functional Class > II
- Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
- Patient understands the implications of participating in the study and provides signed informed consent
Exclusion Criteria:
- Congenital unicuspid or bicuspid aortic valve
- Severe eccentricity of calcification
- Severe mitral regurgitation (> 2°)
- Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- Severe transapical access problem, non-reachable LV apex
- Previous surgery of the LV using a patch, such as the Dor procedure
- Presence of apical LV thrombus
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Acute myocardial infarction (AMI) within 1 month prior to the procedure
- PCI within 1 month prior to the procedure
- Previous transient ischemic attack (TIA) or stroke in the last 3 months
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization
- Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump
- Severe left ventricular dysfunction (LVEF) < 30% by echocardiography
- Calcified pericardium
- Septal hypertrophy unacceptable for transapical procedure
- Primary hypertrophic obstructive cardiomyopathy (HOCM)
- Active infection, endocarditis or pyrexia
- Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
- Significant hepatic involvement (Child > B)
- Severe COPD requiring home oxygen
- History of bleeding diathesis or coagulopathy
- Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3)
- Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis
- Neurological disease severely affecting ambulation or daily functioning, including dementia
- Another surgical or percutaneous procedure scheduled at the same time
- Emergency procedure
- Life expectancy < 12 months due to non-cardiac co-morbid conditions
- Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol
- Currently participating in an investigational drug or another device study
Sites / Locations
- Kerckhoff Klinik GmbH
- Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
- Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
- Klinik für Herzchirurgie GmbH
- Herzzentrum Leipzig GmbH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACURATE TA™
Arm Description
Patient implanted with ACURATE TA™ Bioprosthesis
Outcomes
Primary Outcome Measures
Freedom from all-cause mortality at 30 day Follow Up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Freedom from all-cause mortality at 12 months Follow Up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Secondary Outcome Measures
Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;
2.1 Structural valve deterioration
2.2 Non-structural dysfunction of the implanted study device
2.3 Valve thrombosis, embolism, bleeding event
2.4 Operated valve endocarditis
2.5 Re-intervention on the implanted device
2.6 Valve-related mortality
2.7 Need for new permanent pacemaker or defibrillator within 14 days
Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.
Defined as cardiovascular death, myocardial infarction and stroke
Functional Improvement from baseline
per NYHA functional classification
Procedural success
defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography as assessed at a Core Lab and without intraprocedural mortality.
Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.
Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. The following datapoints will be analyzed:
6.1 Effective orifice area and index (EOA/EOAI)
6.2 Transvalvular Gradients (Peak and mean)
6.3 Paravalvular and intravalvular (Central) leaks
6.4 Aortic Insufficiency
6.5 LV function and hemodynamics
6.6 Valve function and morphology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03143673
Brief Title
ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)
Acronym
TA-PILOT
Official Title
ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2015 (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
The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
Detailed Description
A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Symptomatic 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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACURATE TA™
Arm Type
Experimental
Arm Description
Patient implanted with ACURATE TA™ Bioprosthesis
Intervention Type
Device
Intervention Name(s)
ACURATE TA™
Other Intervention Name(s)
ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System
Intervention Description
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement Surgery.
Primary Outcome Measure Information:
Title
Freedom from all-cause mortality at 30 day Follow Up
Description
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Time Frame
30-Day Follow-up
Title
Freedom from all-cause mortality at 12 months Follow Up
Description
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Time Frame
12 months Follow-Up
Secondary Outcome Measure Information:
Title
Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;
Description
2.1 Structural valve deterioration
2.2 Non-structural dysfunction of the implanted study device
2.3 Valve thrombosis, embolism, bleeding event
2.4 Operated valve endocarditis
2.5 Re-intervention on the implanted device
2.6 Valve-related mortality
2.7 Need for new permanent pacemaker or defibrillator within 14 days
Time Frame
30-Days and at 12 Months Follow-up
Title
Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.
Description
Defined as cardiovascular death, myocardial infarction and stroke
Time Frame
30-Day and 12-Month
Title
Functional Improvement from baseline
Description
per NYHA functional classification
Time Frame
30-Days and 12-Month Follow-up
Title
Procedural success
Description
defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography as assessed at a Core Lab and without intraprocedural mortality.
Time Frame
24 hours Post-Procedure
Title
Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.
Description
Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. The following datapoints will be analyzed:
6.1 Effective orifice area and index (EOA/EOAI)
6.2 Transvalvular Gradients (Peak and mean)
6.3 Paravalvular and intravalvular (Central) leaks
6.4 Aortic Insufficiency
6.5 LV function and hemodynamics
6.6 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 at least 75 years of age
Additive EuroSCORE > 9
Severe AS assessed by echocardiography and documented by a mean gradient > 40mmHg and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²
NYHA Functional Class > II
Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
Patient understands the implications of participating in the study and provides signed informed consent
Exclusion Criteria:
Congenital unicuspid or bicuspid aortic valve
Severe eccentricity of calcification
Severe mitral regurgitation (> 2°)
Pre-existing prosthetic heart valve in any position and / or prosthetic ring
Severe transapical access problem, non-reachable LV apex
Previous surgery of the LV using a patch, such as the Dor procedure
Presence of apical LV thrombus
Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
Acute myocardial infarction (AMI) within 1 month prior to the procedure
PCI within 1 month prior to the procedure
Previous transient ischemic attack (TIA) or stroke in the last 3 months
Untreated clinically significant coronary artery disease (CAD) requiring revascularization
Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump
Severe left ventricular dysfunction (LVEF) < 30% by echocardiography
Calcified pericardium
Septal hypertrophy unacceptable for transapical procedure
Primary hypertrophic obstructive cardiomyopathy (HOCM)
Active infection, endocarditis or pyrexia
Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
Significant hepatic involvement (Child > B)
Severe COPD requiring home oxygen
History of bleeding diathesis or coagulopathy
Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3)
Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis
Neurological disease severely affecting ambulation or daily functioning, including dementia
Another surgical or percutaneous procedure scheduled at the same time
Emergency procedure
Life expectancy < 12 months due to non-cardiac co-morbid conditions
Known hypersensitivity/contraindication to any 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
Thomas Walther, Professor
Organizational Affiliation
Kerckhoff Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerckhoff Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
City
Essen
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinik für Herzchirurgie GmbH
City
Karlsruhe
ZIP/Postal Code
76185
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)
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