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

NCT03143673 | Completed DMC

• 2 other identifiers: 2010-0195.02-5660-6278
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Aortic Symptomatic Stenosis

Keywords

Severe Symptomatic Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Freedom from all-cause mortality at 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

  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 Outcomes (5)

• 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;

  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.

  30-Day and 12-Month

• Functional Improvement from baseline

  30-Days and 12-Month Follow-up

• Procedural success

  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.

  30-Day and 12-Month Follow-up

Study Arms (1)

ACURATE TA™

EXPERIMENTAL

Patient 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 at least 75 years of age
• Additive EuroSCORE \> 9
• 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
• NYHA Functional Class \> II
• Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
• 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 attack (TIA) or stroke in the last 3 months
• Untreated clinically significant coronary artery disease (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 (LVEF) \< 30% by echocardiography
• Calcified pericardium

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (5)

Kerckhoff Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie

Essen, 20246, Germany

Location

Universitätsklinikum Essen Westdeutsches Herzzentrum Essen

Essen, 45122, Germany

Location

Klinik für Herzchirurgie GmbH

Karlsruhe, 76185, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Study Officials

• Thomas Walther, Professor

  Kerckhoff Klinik

  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: December 8, 2014
• First Posted: May 8, 2017
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2015
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

DE (5)