Aortic Stenosis, SevereNCT04944667
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
A study testing TAVR planning in people with Aortic Stenosis, Severe, run by Centro Medico Teknon at 1 site in Spain.
Trial summary
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Severe
- What is being tested?
- TAVR planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe aortic stenosis considered for TAVR procedure at a single Institution
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement (TAVR)
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
Read the 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.
- Conditions
- Aortic Stenosis, Severe
- Being tested
- TAVR planning
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR planningDiagnostic test
TAVR planning without VR vs after VR
| Study group | Role | What they receive |
|---|---|---|
| TAVR standard | Other | TAVR planning evaluated without VR and TAVR planning after VR analysis Receives: Diagnostic Test: TAVR planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAVR procedure planning (prosthesis size, implant technique requirements, potential risks)
Does the TAVR procedure planning change after VR?
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 May 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Collaborators
- Techer Team SL. Valencia. Spain
- Responsible party
- Principal investigator, Eduard Permanyer, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944667
- Sponsor's protocol ID
- Cardiac Surgery CentroMT
- Status last verified
- Mar 2022
- First submitted
- 9 Jun 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement (TAVR)
- ClinicalTrials.gov ID
- NCT04944667
- Acronym / sponsor ID
- Cardiac Surgery CentroMT
- Conditions
- Aortic Stenosis, Severe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Collaborators
- Techer Team SL. Valencia. Spain
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR standard | Other | Diagnostic Test: TAVR planningTAVR planning evaluated without VR and TAVR planning after VR analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Severe aortic stenosis considered for TAVR procedure at a single Institution
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVR planningTAVR planning without VR vs after VR | Diagnostic test | TAVR standard |
Primary outcome
TAVR procedure planning (prosthesis size, implant technique requirements, potential risks)
Time frame: Baseline
Does the TAVR procedure planning change after VR?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR planning in people with Aortic Stenosis, Severe, run by Centro Medico Teknon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAVR procedure planning (prosthesis size, implant technique requirements, potential risks) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.