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ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Primary Purpose

Aortic Stenosis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Transcatheter aortic valve replacement

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Transcatheter Aortic Valve Replacement, TAVI, Transcatheter Aortic Valve Implant, Transfemoral access

Eligibility Criteria

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

Inclusion Criteria:

Patient 75 years of age and older
Severe aortic stenosis defined as:
- Mean aortic gradient > 40 mmHg or
- Peak jet velocity > 4.0 m/s or
- Aortic valve area of < 1.0 cm2
High risk candidate for conventional AVR defined as:
- Logistic EuroSCORE 1 ≥ 20% or
- STS Score ≥ 8% or
- 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
Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT
Patient willing to participate in the study and provides signed informed consent

Exclusion Criteria:

Congenital aortic stenosis or unicuspid or bicuspid aortic valve
Non-stenotic Aortic Insufficiency
Severe eccentricity of calcification
Severe mitral regurgitation (>2+)
Presence of mitral bioprosthesis
Presence of previously implanted aortic bioprosthesis
Presence of prosthetic ring
Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
Thoracic (TAA) or abdominal (AAA) aortic aneurysm
Presence of endovascular stent graft for treatment of TAA or AAA
Trans-oesophageal echocardiogram (TEE) is contraindicated
Evidence of intra-cardiac mass, thrombus or vegetation
Severe ventricular dysfunction with ejection fraction < 20%
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 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
Severe coagulation conditions
Refusal of blood transfusions
Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
Hypertrophic cardiomyopathy with or without obstruction
Active bacterial endocarditis or other active infections
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 or daily functioning, or dementia
Life expectancy < 12 months due to non-cardiac co-morbid conditions
Inability to tolerate anticoagulation therapy
Contraindication to contrast media or allergy to nickel
Currently participating in an investigational drug or another device study
Non-valvular aortic stenosis
Non-calcific acquired aortic stenosis

Sites / Locations

Rigshospitalet
Kerckhoff-Klinik Forschungsgesellschaft mbH
Johannes Hospital
Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie
Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
Herzzentrum Leipzig GmbH
Deutsches Herzzentrum München
Universitätsklinik Regensburg
Luzerner Kantonsspital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACURATE neo AS

Arm Description

Outcomes

Primary Outcome Measures

Rate of all-cause mortality at 30 days follow-up

Secondary Outcome Measures

Rate of clinical events as defined per VARC guidelines

Clinical events: Mortality Stroke Myocardial infarction Bleeding complication Acute kidney injury Vascular complication Conduction disturbances and arrhythmia Other TAVI-related complications

Procedural success

2. Procedural success defined as absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one aortic bioprosthesis (valve in valve); or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication

Device success

3. Device success defined as: Absence of intra-procedure mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (EOAi >0.85 cm2/m2 and mean aortic valve gradient <20mmHg without moderate or severe AR)

VARC Composite Safety at 30 days

Clinical improvement from baseline as per NYHA Functional Classification

Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient

Total aortic regurgitation

Full Information

NCT ID

NCT02909556

First Posted

September 16, 2016

Last Updated

February 15, 2023

Sponsor

Symetis SA

1. Study Identification

Unique Protocol Identification Number

NCT02909556

Brief Title

ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Official Title

ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

December 16, 2016 (Actual)

Primary Completion Date

January 24, 2018 (Actual)

Study Completion Date

January 13, 2023 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.

Detailed Description

Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery. The 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

Transcatheter Aortic Valve Replacement, TAVI, Transcatheter Aortic Valve Implant, Transfemoral access

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACURATE neo AS

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Transcatheter aortic valve replacement

Other Intervention Name(s)

ACURATE neo™ AS Aortic Bioprosthesis (Commercial name: ACURATE neo2™ Aortic Valve), ACURATE neo™ AS TF Transfemoral Delivery System (Commercial name: ACURATE neo2™ Transfemoral Delivery System)

Intervention Description

Transcatheter aortic valve replacement via transfemoral access

Primary Outcome Measure Information:

Title

Rate of all-cause mortality at 30 days follow-up

Time Frame

30 days post-implant

Secondary Outcome Measure Information:

Title

Rate of clinical events as defined per VARC guidelines

Description

Clinical events: Mortality Stroke Myocardial infarction Bleeding complication Acute kidney injury Vascular complication Conduction disturbances and arrhythmia Other TAVI-related complications

Time Frame

7 days, 30 days, 12 months post-implant

Title

Procedural success

Description

Time Frame

Day of implant

Title

Device success

Description

Time Frame

Day of implant

Title

VARC Composite Safety at 30 days

Time Frame

30 days

Title

Clinical improvement from baseline as per NYHA Functional Classification

Time Frame

7 days, 30 days, 12 months post-implant

Title

Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient

Time Frame

7 days, 30 days, 12 months

Title

Total aortic regurgitation

Time Frame

7 days, 30 days, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient 75 years of age and older Severe aortic stenosis defined as: Mean aortic gradient > 40 mmHg or Peak jet velocity > 4.0 m/s or Aortic valve area of < 1.0 cm2 High risk candidate for conventional AVR defined as: Logistic EuroSCORE 1 ≥ 20% or STS Score ≥ 8% or 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 Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT Patient willing to participate in the study and provides signed informed consent Exclusion Criteria: Congenital aortic stenosis or unicuspid or bicuspid aortic valve Non-stenotic Aortic Insufficiency Severe eccentricity of calcification Severe mitral regurgitation (>2+) Presence of mitral bioprosthesis Presence of previously implanted aortic bioprosthesis Presence of prosthetic ring Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries Thoracic (TAA) or abdominal (AAA) aortic aneurysm Presence of endovascular stent graft for treatment of TAA or AAA Trans-oesophageal echocardiogram (TEE) is contraindicated Evidence of intra-cardiac mass, thrombus or vegetation Severe ventricular dysfunction with ejection fraction < 20% 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 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 Severe coagulation conditions Refusal of blood transfusions Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP Hypertrophic cardiomyopathy with or without obstruction Active bacterial endocarditis or other active infections 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 or daily functioning, or dementia Life expectancy < 12 months due to non-cardiac co-morbid conditions Inability to tolerate anticoagulation therapy Contraindication to contrast media or allergy to nickel Currently participating in an investigational drug or another device study Non-valvular aortic stenosis Non-calcific acquired aortic stenosis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helge Möllmann, Prof.

Organizational Affiliation

Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Kerckhoff-Klinik Forschungsgesellschaft mbH

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Johannes Hospital

City

Dortmund

Country

Germany

Facility Name

Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Herzzentrum Leipzig GmbH

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

Facility Name

Deutsches Herzzentrum München

City

München

ZIP/Postal Code

80636

Country

Germany

Facility Name

Universitätsklinik Regensburg

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Luzerner Kantonsspital

City

Luzern

ZIP/Postal Code

6000

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Learn more about this trial

ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

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