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

November 22, 2018 updated by: Symetis SA
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

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 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.

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.
89

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

  • Brazil
      • Sao Paulo, Brazil, CEP 04012-909
        • Instituto Dante Pazzanese de Cardiologia
  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik GmbH
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Hamburg
      • Köln, Germany, 50937
        • Herzzentrum Universitätsklinikum Koln
  • Japan
      • Osaka, Japan
        • Osaka University Hospital

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

Genders Eligible for Study

All

Description

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

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: Symetis ACURATE TF™
Patient implanted with ACURATE TF™Bioprosthesis.
Device: ACURATE TF™
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 .
Other Names:
  • ACURATE TF™Transfemoral 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
Time Frame: 30-Day Follow-up
Rate of all-cause mortality
30-Day 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 MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.
Time Frame: 30-Days and 12 Months Follow-up
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.
30-Days and 12 Months Follow-up
Change in NYHA class over time
Time Frame: 30-Day and 12-Month
Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.
30-Day and 12-Month
Procedural success during device implantation
Time Frame: intraoperative
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.
intraoperative
Device success
Time Frame: 30-Day and 12-Month Follow-up

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
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

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.
September 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, 2013

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.
August 1, 2017

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 2, 2016

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.
December 21, 2016

First Posted (Estimate)

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.
December 28, 2016

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.
November 27, 2018

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.
November 22, 2018

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.
November 1, 2018

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.
  • TF89

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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