NCT03454360

Brief Summary

The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System. Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population. As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

July 31, 2017

Last Update Submit

December 10, 2020

Conditions

Aortic Stenosis

Keywords

TAVITranscatheter Aortic Valve ReplacementTranscatheter Aortic ValveTransapical Access

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    the rate of all-cause mortality as measured at 30-days

    30 days

Secondary Outcomes (7)

  • Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.

    Procedure to Discharge, 30 days and 12-months

  • Procedural Success

    Procedure to 24-hours

  • Device Success

    Post-procedure to Discharge.

  • VARC 2 Composite Safety

    30-days

  • Functional improvement as per NYHA Functional Classification

    from baseline to, discharge, 30-days and 12-months follow-up.

  • +2 more secondary outcomes

Interventions

ACURATE neo™ Aortic BioprosthesisDEVICE

TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.

Also known as: ACURATE neo™ TA Delivery System

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects with severe aortic stenosis, for whom the transapical access is the most suitable approach as per heart-team consensus, who signed the Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC), and are deemed to be candidates to undergo transcatheter aortic valve implantation with the ACURATE neo™ Aortic Bioprosthesis and its Transapical Delivery System as per clinical practice at each participating site

You may qualify if:

  • Symptomatic patients with severe aortic stenosis;
  • Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;

You may not qualify if:

  • \- Patients unable or unwilling to give inform consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Herz-und Gefäß-Kilink GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Krankenhausbetriebgesellschaft

Bad Oeynhausen, D-32545, Germany

Location

BG Klinik Bergmannsheil

Bochum, 44789, Germany

Location

Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie

Frankfurt, 60590, Germany

Location

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Michael Hilker, Prof.Dr.med

    Universitätsklinikum Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

March 5, 2018

Study Start

February 6, 2018

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

December 11, 2020

Record last verified: 2020-12

Locations

DE(10)