Structural Cardiac DefectsNCT05514626
Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures
An observational study of Structural Cardiac Defects, run by RealView Imaging at 1 site in United States.
Trial summary
This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Structural Cardiac Defects
- What is being tested?
- 3D Holographic Display
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 30 Jun 2023
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Up to Fifty (50) patients undergoing elective procedures which use 3D echocardiography for treatment of structural heart disease.
Who may be able to join
- Patients over the age of 18
- Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure.
Who cannot join
- Denial of informed consent
- Any contraindications to three-dimensional echocardiographic imaging.
Trial locations and contacts
1 site in 1 country.
About this study
This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.
- Conditions
- Structural Cardiac Defects
- Being tested
- 3D Holographic Display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Holographic DisplayDevice
3D holographic visualization of the anatomy during the planned interventional procedure. The HOLOSCOPE-i will be used in addition to and will not replace conventional displays that are currently being used during the procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures
Qualitative assessment using a Likert scale
Measured: During procedure
Secondary outcomes (3)
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy
Qualitative assessment using a Likert scale
Measured: During procedure
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy
Qualitative assessment using a Likert scale
Measured: During procedure
Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions
Qualitative assessment using a Likert scale
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start24 Mar 2022
- Primary completion15 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Cardiac DefectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RealView Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514626
- Sponsor's protocol ID
- 20-14-001
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures
- ClinicalTrials.gov ID
- NCT05514626
- Acronym / sponsor ID
- 20-14-001
- Conditions
- Structural Cardiac Defects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RealView ImagingIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Aug 2022 (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 is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Up to Fifty (50) patients undergoing elective procedures which use 3D echocardiography for treatment of structural heart disease.
Key inclusion criteria (2 listed)
- Patients over the age of 18
- Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure.
Key exclusion criteria (2 listed)
- Denial of informed consent
- Any contraindications to three-dimensional echocardiographic imaging.
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 |
|---|---|---|
| 3D Holographic Display3D holographic visualization of the anatomy during the planned interventional procedure. The HOLOSCOPE-i will be used in addition to and will not replace conventional displays that are currently being used during the procedure. | Device | – |
Primary outcome
HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures
Time frame: During procedure
Qualitative assessment using a Likert scale
3 secondary outcomes
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy
Time frame: During procedure
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy
Time frame: During procedure
Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Structural Cardiac Defects
RecruitingPhase 3
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
Congenital Heart Disease
RecruitingObservational study
Abbott Structural Heart Device Registry
Heart Diseases, ASD - Atrial Septal Defect
RecruitingObservational study
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Muscular Ventricular Septal Defect
Active, not recruitingObservational study
Early Warning of Structural Complications in Perimembranous VSD
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
Active, not recruiting
The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease
Congenital Heart Disease, Dysbiosis
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?
An observational study of Structural Cardiac Defects, run by RealView Imaging at 1 site in United States.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Aug 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 United States. 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?
Results are not available in the source record.
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?
HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures (time frame: During procedure). 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 24 Aug 2022.