ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis

NCT02950428 | Completed DMC

• 1 other identifier: 2015-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.

Conditions

Aortic Stenosis

Keywords

TAVI; Aortic Stenosis; transcatether Aortic Valve Implantation

Outcome Measures

Primary Outcomes (2)

• Primary Safety: freedom from all-cause mortality

  freedom from all-cause mortality

  6 months post procedure

• Primary Device Performance:Procedure success in absence of MACCE

  Procedure success in absence of MACCE

  30 days post procedure

Secondary Outcomes (7)

• Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines

  30 Days and month 12

• Incidence of all cause mortality at 30 Days and 12 Months

  30 days and 12 months

• Freedom from MACCE at 30 Days, 6 Months and 12 Months

  30 Days, 6 Months and 12 Months

• Number of patients who have a Procedural success defined by a combination of criteria

  procedure

• Rate of device success

  7 days/ Discharge, 30 Days, 6 Months and at 12 Months

Study Arms (1)

ACURATE neo™TA Delivery System

EXPERIMENTAL

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

Device: ACURATE neo™TA Delivery System

Interventions

ACURATE neo™TA Delivery System DEVICE

ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA 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™TA Delivery System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years old
• Severe aortic stenosis defined as:
• Mean aortic gradient \> 40 mmHg or
• Peak jet velocity \> 4.0 m/s or
• Aortic valve area of \< 0.8 cm2
• High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum
• NYHA Functional Class \> II
• Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions:
• porcelain aorta or
• severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or
• vessels too small for retrograde approach or
• other anatomical conditions making transapical approach more suitable
• 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 or non-calcified
• Extreme eccentricity of calcification
• Severe mitral regurgitation (\> Grade 3)
• 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 \< 20% by ECHO
• Need for emergency intervention for any reason within 30 Days of scheduled procedure
• Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
• Untreated clinically significant coronary artery disease requiring revascularization within 30 days before or after the study procedure

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (7)

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Krankenhausbetriebsgesellschaft

Bad Oeynhausen, 32545, Germany

Location

Deutsched Herzzentrum Berlin

Berlin, 13353, Germany

Location

Martin Luther University Halle Winttenberg

Halle, 06112, Germany

Location

Universitätklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Herzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

University Hospital Regensburg

Regensburg, 93053, Germany

Location

Related Publications (1)

• Conradi L, Hilker M, Kempfert J, Borgermann J, Treede H, Holzhey DM, Schrofel H, Kim WK, Schaefer U, Walther T. Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes. Eur J Cardiothorac Surg. 2018 Oct 1;54(4):762-767. doi: 10.1093/ejcts/ezy097.

  PMID: 29554265 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Markus Pr Schönburg, Prof.Dr.Med

  Abteilung Herzchirurgie 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: February 12, 2016
• First Posted: November 1, 2016
• Study Start: November 18, 2015
• Primary Completion: April 17, 2017
• Study Completion: September 3, 2021
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

DE (7)