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Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement

NCT ID: NCT04944667

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-05-31

Brief Summary

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

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Detailed Description

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A prospective study involving 11 patients referred for TAVR was conducted. A multidetector computed tomography (MDCT) was used to acquire and segment the anatomy of the access route and landing zone. From the information obtained with the MDCT in DICOM format, the investigators built a virtual platform (VisuaMed, Teacher Team. Valencia. Spain) that contains all the clinical information of the patients and a virtualized model of their anatomy. Wearing VR devices, the professional was able to "walk inside " the anatomy in an interactive and immersive way. Decisions after the evaluation of routine clinical images were compared with those after experience with VR models and intraprocedural findings.

Conditions

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Aortic Stenosis, Severe

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TAVR standard

TAVR planning evaluated without VR and TAVR planning after VR analysis

Group Type OTHER

TAVR planning

Intervention Type DIAGNOSTIC_TEST

TAVR planning without VR vs after VR

Interventions

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TAVR planning

TAVR planning without VR vs after VR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Techer Team SL. Valencia. Spain

UNKNOWN

Sponsor Role collaborator

Centro Medico Teknon

OTHER

Sponsor Role lead

Responsible Party

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Eduard Permanyer

Md,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CentroMT (Centro Médico Teknon)

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Cardiac Surgery CentroMT

Identifier Type: -

Identifier Source: org_study_id

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