NCT02909556

Brief Summary

Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
3 countries

9 active sites

Status
completed

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

September 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 16, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

September 16, 2016

Last Update Submit

February 15, 2023

Conditions

Aortic Stenosis

Keywords

Transcatheter Aortic Valve ReplacementTAVITranscatheter Aortic Valve ImplantTransfemoral access

Outcome Measures

Primary Outcomes (1)

  • Rate of all-cause mortality at 30 days follow-up

    30 days post-implant

Secondary Outcomes (7)

  • Rate of clinical events as defined per VARC guidelines

    7 days, 30 days, 12 months post-implant

  • Procedural success

    Day of implant

  • Device success

    Day of implant

  • VARC Composite Safety at 30 days

    30 days

  • Clinical improvement from baseline as per NYHA Functional Classification

    7 days, 30 days, 12 months post-implant

  • +2 more secondary outcomes

Study Arms (1)

ACURATE neo AS

EXPERIMENTAL
Device: Transcatheter aortic valve replacement

Interventions

Transcatheter aortic valve replacementDEVICE

Transcatheter aortic valve replacement via transfemoral access

Also known as: ACURATE neo™ AS Aortic Bioprosthesis (Commercial name: ACURATE neo2™ Aortic Valve), ACURATE neo™ AS TF Transfemoral Delivery System (Commercial name: ACURATE neo2™ Transfemoral Delivery System)
ACURATE neo AS

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient 75 years of age and older
  • Severe aortic stenosis defined as:
  • Mean aortic gradient \> 40 mmHg or
  • Peak jet velocity \> 4.0 m/s or
  • Aortic valve area of \< 1.0 cm2
  • High risk candidate for conventional AVR defined as:
  • Logistic EuroSCORE 1 ≥ 20% or
  • STS Score ≥ 8% or
  • 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
  • Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT
  • Patient willing to participate in the study and provides signed informed consent

You may not qualify if:

  • Congenital aortic stenosis or unicuspid or bicuspid aortic valve
  • Non-stenotic Aortic Insufficiency
  • Severe eccentricity of calcification
  • Severe mitral regurgitation (\>2+)
  • Presence of mitral bioprosthesis
  • Presence of previously implanted aortic bioprosthesis
  • Presence of prosthetic ring
  • Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
  • Thoracic (TAA) or abdominal (AAA) aortic aneurysm
  • Presence of endovascular stent graft for treatment of TAA or AAA
  • Trans-oesophageal echocardiogram (TEE) is contraindicated
  • Evidence of intra-cardiac mass, thrombus or vegetation
  • Severe ventricular dysfunction with ejection fraction \< 20%
  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Kerckhoff-Klinik Forschungsgesellschaft mbH

Bad Nauheim, 61231, Germany

Location

Johannes Hospital

Dortmund, Germany

Location

Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie

Halle, 06120, Germany

Location

Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

Universitätsklinik Regensburg

Regensburg, 93053, Germany

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Helge Möllmann, Prof.

    Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany

    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

September 16, 2016

First Posted

September 21, 2016

Study Start

December 16, 2016

Primary Completion

January 24, 2018

Study Completion

January 13, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

DK(1)DE(7)CH(1)