ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01) (TA-PILOT)

July 25, 2023 updated by: Symetis SA

ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik GmbH
      • Essen, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
      • Essen, Germany, 45122
        • Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
      • Karlsruhe, Germany, 76185
        • Klinik für Herzchirurgie GmbH
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

71 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients at least 75 years of age
  2. Additive EuroSCORE > 9
  3. 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
  4. NYHA Functional Class > II
  5. Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
  6. Patient understands the implications of participating in the study and provides signed informed consent

Exclusion Criteria:

  1. Congenital unicuspid or bicuspid aortic valve
  2. Severe eccentricity of calcification
  3. Severe mitral regurgitation (> 2°)
  4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
  5. Severe transapical access problem, non-reachable LV apex
  6. Previous surgery of the LV using a patch, such as the Dor procedure
  7. Presence of apical LV thrombus
  8. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  9. Acute myocardial infarction (AMI) within 1 month prior to the procedure
  10. PCI within 1 month prior to the procedure
  11. Previous transient ischemic attack (TIA) or stroke in the last 3 months
  12. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  13. Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump
  14. Severe left ventricular dysfunction (LVEF) < 30% by echocardiography
  15. Calcified pericardium
  16. Septal hypertrophy unacceptable for transapical procedure
  17. Primary hypertrophic obstructive cardiomyopathy (HOCM)
  18. Active infection, endocarditis or pyrexia
  19. Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
  20. Significant hepatic involvement (Child > B)
  21. Severe COPD requiring home oxygen
  22. History of bleeding diathesis or coagulopathy
  23. Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3)
  24. Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis
  25. Neurological disease severely affecting ambulation or daily functioning, including dementia
  26. Another surgical or percutaneous procedure scheduled at the same time
  27. Emergency procedure
  28. Life expectancy < 12 months due to non-cardiac co-morbid conditions
  29. Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol
  30. Currently participating in an investigational drug or another device study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACURATE TA™
Patient implanted with ACURATE TA™ Bioprosthesis
Device: ACURATE TA™
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.
Other Names:
  • ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from all-cause mortality at 30 day Follow Up
Time Frame: 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.
30-Day Follow-up
Freedom from all-cause mortality at 12 months Follow Up
Time Frame: 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.
12 months Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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;
Time Frame: 30-Days and at 12 Months Follow-up

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
30-Days and at 12 Months Follow-up
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.
Time Frame: 30-Day and 12-Month
Defined as cardiovascular death, myocardial infarction and stroke
30-Day and 12-Month
Functional Improvement from baseline
Time Frame: 30-Days and 12-Month Follow-up
per NYHA functional classification
30-Days and 12-Month Follow-up
Procedural success
Time Frame: 24 hours Post-Procedure
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.
24 hours Post-Procedure
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.
Time Frame: 30-Day and 12-Month Follow-up

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
30-Day and 12-Month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Symetis SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Walther, Professor, Kerckhoff Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010-01 (internal number)
  • 95.02-5660-6278 (Other Identifier: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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