NCT03003650

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

December 2, 2016

Last Update Submit

November 22, 2018

Conditions

Symptomatic Aortic Stenosis

Keywords

Severe Symptomatic Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Freedom from all-cause mortality

    Rate of all-cause mortality

    30-Day Follow-up

Secondary Outcomes (4)

  • Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.

    30-Days and 12 Months Follow-up

  • Change in NYHA class over time

    30-Day and 12-Month

  • Procedural success during device implantation

    intraoperative

  • Device success

    30-Day and 12-Month Follow-up

Study Arms (1)

Symetis ACURATE TF™

EXPERIMENTAL

Patient implanted with ACURATE TF™Bioprosthesis.

Device: ACURATE TF™

Interventions

ACURATE TF™DEVICE

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 .

Also known as: ACURATE TF™Transfemoral Aortic Bioprosthesis and Delivery System
Symetis ACURATE TF™

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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 of \< 1.0 cm2
  • New York Heart Association (NYHA) Functional Class \> II
  • Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (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

You may not qualify if:

  • 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
  • TEE is contraindicated
  • Left Ventricular 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 Transien 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Instituto Dante Pazzanese de Cardiologia

São Paulo, CEP 04012-909, Brazil

Location

Kerckhoff Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Herzzentrum Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Osaka University Hospital

Osaka, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 28, 2016

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

August 1, 2017

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

BR(1)JP(1)DE(4)