Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)

NCT03567278 | Completed DMC

• 2 other identifiers: 2009-01DE/CA84/73-KL-30-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Conditions

Aortic Stenosis Symptomatic

Keywords

Severe Symptomatic Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Safety endpoint

  Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE

  30 days

Secondary Outcomes (5)

• Performance endpoint

  Up to 24-hours post-procedure

• Performance endpoint

  Up to 24-hours post-procedure

• Mortality

  30 days, 60 days, 3 months, 6 months and 12 months

• MAVRE at follow-up

  discharge or 7 days, 3 months, 6 months and 12 months

• MACCE or Major Adverse Cardiac and Cerebrovascular Event

  1 month, 3 months, 6 months and 12 months

Study Arms (1)

ACURATE TA™

EXPERIMENTAL

Patients implanted with ACURATE TA™ Bioprosthesis

Device: ACURATE TA™

Interventions

ACURATE TA™ DEVICE

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.

Also known as: ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System

ACURATE TA™

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients older than 75 years;
• Additive EuroSCORE \> 9 and/or STS \> 9%;
• Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient \> 40mmHg,and a native Aortic Valve Area (AVA) \< 0.8 cm² or Aortic Valve Area Index (AVAI) \< 0.6 cm²/m²;
• NYHA Functional Class \> II;
• Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography;
• Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) \[STJ\>1.1xAAn\] AND STJ\<45mm by transoesophageal echocardiography;
• Patient understands the implications of participating in the study and provides signed informed consent

You may not qualify if:

• Congenital unicuspid or bicuspid aortic valve;
• Severe eccentricity of calcification;
• Severe mitral regurgitation (\> 2°);
• Pre-existing prosthetic heart valve in any position and /or prosthetic ring;
• Severe transapical access problem, non-reachable LV apex;
• Previous surgery of the LV using a patch, such as the Dor procedure;
• Presence of apical LV thrombus;
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
• Acute Myocardial Infarction (AMI) within 1 month prior to the procedure;
• PCI within 1 month prior to the procedure;
• Previous Transient Ischemic Accident (TIA) or stroke in the last 3 months;
• Untreated clinically significant CAD requiring revascularization;
• Hemodynamic instability: systolic pressure \<90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump;
• Severe left ventricular dysfunction with a LV Ejection Fraction (LVEF) \< 25% by echocardiography;
• Calcified pericardium;

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (5)

Kerckhoff Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Universitätsklinikum Essen Westdeutsches Herzzentrum Essen

Essen, 45122, Germany

Location

Universitätsklinikum Freiburg Herz- und Gefäßchirurgie

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefäßchirurgie

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Study Officials

• Friedrich Mohr, Professor

  Herzzentrum Leipzig GmbH

  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

Model Details: Medical Device Study

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: June 25, 2018
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2015
• Last Updated: June 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)