Back to resultsUse of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
Primary Purpose
Aortic Stenosis, Severe
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAVR planning
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Stenosis, Severe
Eligibility Criteria
Inclusion Criteria:
- Severe aortic stenosis considered for TAVR procedure at a single Institution
Exclusion Criteria:
- None
Sites / Locations
- CentroMT (Centro Médico Teknon)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
TAVR standard
Arm Description
TAVR planning evaluated without VR and TAVR planning after VR analysis
Outcomes
Primary Outcome Measures
TAVR procedure planning (prosthesis size, implant technique requirements, potential risks)
Does the TAVR procedure planning change after VR?
Secondary Outcome Measures
Full Information
NCT ID
NCT04944667
First Posted
June 9, 2021
Last Updated
March 8, 2022
Sponsor
Centro Medico Teknon
Collaborators
Techer Team SL. Valencia. Spain
1. Study Identification
Unique Protocol Identification Number
NCT04944667
Brief Title
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
Official Title
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement (TAVR)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Medico Teknon
Collaborators
Techer Team SL. Valencia. Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Severe
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAVR standard
Arm Type
Other
Arm Description
TAVR planning evaluated without VR and TAVR planning after VR analysis
Intervention Type
Diagnostic Test
Intervention Name(s)
TAVR planning
Intervention Description
TAVR planning without VR vs after VR
Primary Outcome Measure Information:
Title
TAVR procedure planning (prosthesis size, implant technique requirements, potential risks)
Description
Does the TAVR procedure planning change after VR?
Time Frame
Baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe aortic stenosis considered for TAVR procedure at a single Institution
Exclusion Criteria:
None
Facility Information:
Facility Name
CentroMT (Centro Médico Teknon)
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
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