ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)

NCT03752996 | Completed DMC

• 1 other identifier: 2011-03
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 5

Brief Summary

First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Conditions

Aortic Stenosis Symptomatic

Outcome Measures

Primary Outcomes (1)

• Freedom from all-cause mortality

  Rate of all-cause mortality

  30-Days

Secondary Outcomes (1)

• Rate of MACCE (major cardiac and cerebrovascular event)

  30-Days and 12-Months

Study Arms (1)

ACURATE TF™ Aortic Valve System

EXPERIMENTAL

ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement .

Device: ACURATE TF™ Aortic Valve System

Interventions

ACURATE TF™ Aortic Valve System DEVICE

Transcatheter Aortic Valve Implantation

ACURATE TF™ Aortic Valve System

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older 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 \< 1.0 cm2
• New York Heart Association (NYHA) Functional Class \> II
• Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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
• Trans-esophageal echocardiogram (TEE) is contraindicated
• Left Ventricle 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 Transient 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

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (5)

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

Study Officials

• Won Keun Kim, Dr. Med.

  Kerckhoff Klinik Bad Nauheim, Germany

  PRINCIPAL INVESTIGATOR

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: November 21, 2018
• First Posted: November 26, 2018
• Study Start: May 9, 2012
• Primary Completion: June 30, 2017
• Study Completion: March 30, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); DE (4)