NCT04944667

Brief Summary

This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

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

May 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

June 9, 2021

Last Update Submit

March 8, 2022

Conditions

Aortic Stenosis, Severe

Outcome Measures

Primary Outcomes (1)

  • TAVR procedure planning (prosthesis size, implant technique requirements, potential risks)

    Does the TAVR procedure planning change after VR?

    Baseline

Study Arms (1)

TAVR standard

OTHER

TAVR planning evaluated without VR and TAVR planning after VR analysis

Diagnostic Test: TAVR planning

Interventions

TAVR planningDIAGNOSTIC_TEST

TAVR planning without VR vs after VR

TAVR standard

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe aortic stenosis considered for TAVR procedure at a single Institution

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CentroMT (Centro Médico Teknon)

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md,PhD

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 29, 2021

Study Start

May 1, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)