ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis

NCT02986737 | Completed DMC

• 1 other identifier: 2014-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device

Conditions

Aortic Stenosis

Keywords

TAVI; Aortic Stenosis; Transcatether Aortic Valve Implantation

Outcome Measures

Primary Outcomes (2)

• All cause mortality

  incidence of all cause mortality at 30 days

  30 days

• Mean aortic gradient after device implantation

  mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up

  7 days or Discharge

Secondary Outcomes (4)

• rate of clinical endpoints VARC II

  30 days and month 12

• procedural success

  procedure

• device success assessed according to composite VARC 2 criteria

  7 days, 30 days, 12 months

• functional improvement from Baseline as per NYHA Functional Classification

  30 days and 12 months follow up

Study Arms (1)

ACURATE neo™ and ACURATE TA™ LP

EXPERIMENTAL

Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System

Device: ACURATE neo™ and ACURATE TA™ LP

Interventions

ACURATE neo™ and ACURATE TA™ LP DEVICE

ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk

ACURATE neo™ and ACURATE TA™ LP

Eligibility Criteria

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

You may qualify if:

• Patient 75 years of age and older
• Severe aortic stenosis defined as:
• Mean aortic gradient \> 40mmHg or o Peak jet velocity \> 4.0m/sor Aortic valve area of \< 1.0cm2
• High risk candidate for conventional AVR defined as:
• STS score ≥ 10 or Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co- morbid conditions unrelated to aortic stenosis
• NYHA Functional Class \> II
• Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route
• Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE
• Patient willing to participate in the study and provides signed informed consent

You may not qualify if:

• Congenital unicuspid or bicuspid aortic valve
• Extreme eccentricity of calcification
• Severe mitral regurgitation (\> Grade 2)
• Pre-existing prosthetic heart valve in any position and / or prosthetic ring
• LV apex is not accessible via transapical access due to severe chest deformity
• Previous surgery of the LV using a patch, such as the Dor procedure
• Presence of apical LV thrombus
• Calcified pericardium
• Septal hypertrophy unacceptable for transapical procedure
• Transesophageal echocardiogram (TEE) is contraindicated
• ECHO evidence of intracardiac mass, thrombus, or vegetation
• LVEF \< 30% by ECHO
• Emergency procedure pre-implant including CAD requiring revascularization
• Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
• Acute myocardial infarction within 1 month prior to implant procedure

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (2)

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Klinik für Herz-und Gefäßchirurgie

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Mirko Doss, Prof.Dr.Med

  Abteilung Herzchirurgie Kerckhoff-Klinik

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Medical device trial

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: December 8, 2014
• Primary Completion: March 3, 2015
• Study Completion: October 1, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)