NCT04473443

Brief Summary

The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

July 13, 2020

Last Update Submit

July 25, 2022

Conditions

Aortic Valve StenosisBicuspid Cardiac Valve

Outcome Measures

Primary Outcomes (1)

  • overall device success conform the VARC-2 document

    * Incidence of mortality * incidence of stroke * incidence of major vascular complication * incidence of life-threatening bleeding

    30 days after TAVI

Secondary Outcomes (2)

  • incidence of more than trivial PVL

    30 days after TAVI

  • conduction abnormalities and need for new permanent pacemaker implantation

    30 days after TAVI

Study Arms (2)

Cohort A

Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots

Other: FEops HEARTguideTM

Cohort B

Consecutive patients eligible for TAVI with ACURATE-NEO2 valve

Other: FEops HEARTguideTM

Interventions

FEops HEARTguideTMOTHER

A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.

Cohort ACohort B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This prospective multi-center international Registry of TAVI patients include for Cohort A patients with the following complex anatomy: BAV (Sievers 0 or 1) or functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots. And for Cohort B consecutive patients eligible for TAVI with ACURATE-NEO2-valve

You may qualify if:

  • Cohort A:
  • Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve
  • Patients with a severely calcified aortic valve (Agatston score \> 3000 for men, and \> 1600 for women)
  • Patients with small anatomy defined by mean aortic annulus diameter \< 20mm
  • Cohort B:
  • every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.

You may not qualify if:

  • poor CT quality
  • previous aortic valve replacement
  • Permanent pacemaker at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015GD, Netherlands

RECRUITING

Related Publications (1)

  • Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.

    PMID: 23084102BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Nicolas van Mieghem, Md,PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas van Mieghem, MD, PhD

CONTACT

+31107035260n.vanmieghem@erasmusmc.nl

Thijmen Hokken, MD

CONTACT

+31107038896t.hokken@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 16, 2020

Study Start

August 1, 2020

Primary Completion

February 1, 2023

Study Completion

June 30, 2023

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations

NL(1)