NCT02306226

Brief Summary

Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

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

Study Start

First participant enrolled

September 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

September 2, 2014

Last Update Submit

March 15, 2018

Conditions

Aortic Stenosis

Keywords

TAVIAortic stenosisTranscatheter aortic valve replacementTranscatheter aortic valve implantationTransfemoral access

Outcome Measures

Primary Outcomes (1)

  • Rate of all-cause mortality

    30 days

Other Outcomes (4)

  • Rate of clinical endpoints (VARC 2)

    Procedure, 7 days or discharge (whichever occurs first), 30 days, 12 months

  • Procedural success

    Post-implantation

  • Device success

    7 days or discharge (whichever occurs first), 12 months

  • +1 more other outcomes

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As the ACURATE neo™ is approved for use to treat patients with severe aortic stenosis, the inclusion criteria are broad in order to allow the device to be used in an all-comers population and following the Instructions For Use.

You may qualify if:

  • Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use
  • Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry
  • The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

You may not qualify if:

  • \. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Helge Möllmann, Prof.

    Kerckhoff Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

December 3, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

April 1, 2017

Last Updated

March 19, 2018

Record last verified: 2018-03