Severe Aortic Valve StenosisTAVI_VRNCT04259723
Virtual Reality Assisted Conscious Sedation During TAVI
A study testing VR during TAVI in people with Severe Aortic Valve Stenosis and Anxiety, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis, Anxiety, Pain
- What is being tested?
- VR during TAVI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 1 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Interventional transfemoral TAVI
- Informed consent
- Normal or corrected vision (through glasses)
Who cannot join
- Patients whose communication is limited due to a language barrier
- Patients who could not watch the 3D video due to uncorrectable vision
- all patients with transapical TAVI were also excluded.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.
- Conditions
- Severe Aortic Valve Stenosis, Anxiety, Pain
- Being tested
- VR during TAVI
- Keywords
- TAVI, VR, 3D glasses
- Medical subject headings
- Aortic Valve Stenosis, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR during TAVIOther
Virtual Reality (VR) glasses
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: VR during TAVI |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)
Measured: at Baseline
Change in anxiety
A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)
Measured: after 24 hours
Secondary outcomes (7)
Time of VR
The time [min] of VR use will be recorded during the procedure
Measured: at Baseline
Evaluation of clinical frailty scale
The Clinical Frailty Scale (CFS) is a simple model visually describing patients physical conditions with nine classes from very fit (class 1) to terminally ill (class 9).
Measured: at Baseline
Measurement of pain: visual analog scale
A visual analog scale will be used to determine the level of pain after the procedure. A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no pain, 10=unbearable pain)
Measured: after 24 hours
Length of stay at hospital
The length of stay at hospital will be recorded.
Measured: up to 5 days
Occurence of vomitting
Patients will be asked during and after the procedure for safety problems with special regards to vomiting
Measured: at Baseline, periprocedural and after 24 hours
Occurence of nausea
Patients will be asked during and after the procedure for safety problems with special regards to nausea
Measured: at Baseline, periprocedural and after 24 hours
Rate of Intra-hospital mortality
The intra-hospital mortality will be assessed after discharge
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Nov 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic Valve StenosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259723
- Sponsor's protocol ID
- 19-007
- Acronym
- TAVI_VR
- Status last verified
- Jun 2020
- First submitted
- 29 Jan 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04259723
- Acronym / sponsor ID
- TAVI_VR / 19-007
- Conditions
- Severe Aortic Valve Stenosis, Anxiety, Pain
- Keywords
- TAVI, VR, 3D glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 6 Feb 2020 (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.
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: VR during TAVI |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Interventional transfemoral TAVI
- Informed consent
- Normal or corrected vision (through glasses)
Key exclusion criteria (3 listed)
- Patients whose communication is limited due to a language barrier
- Patients who could not watch the 3D video due to uncorrectable vision
- all patients with transapical TAVI were also excluded.
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 |
|---|---|---|
| VR during TAVIVirtual Reality (VR) glasses | Other | Intervention |
Primary outcome
Change in anxiety
Time frame: at Baseline
A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)
Change in anxiety
Time frame: after 24 hours
A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)
7 secondary outcomes
Time of VR
Time frame: at Baseline
Evaluation of clinical frailty scale
Time frame: at Baseline
Measurement of pain: visual analog scale
Time frame: after 24 hours
Length of stay at hospital
Time frame: up to 5 days
Occurence of vomitting
Time frame: at Baseline, periprocedural and after 24 hours
Occurence of nausea
Time frame: at Baseline, periprocedural and after 24 hours
Rate of Intra-hospital mortality
Time frame: up to 5 days
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 18 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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 VR during TAVI in people with Severe Aortic Valve Stenosis and Anxiety, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
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 3 inclusion and 3 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 18 Jun 2020. 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 Germany. 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?
Change in anxiety (time frame: at Baseline). The study lists 2 primary outcomes in all. 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 18 Jun 2020.