Aortic Valve InsufficiencyOVALNCT04047082
Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab
An observational study of Aortic Valve Insufficiency and Heart Valve Diseases, run by Imperial College London at 1 site in Netherlands.
Trial summary
Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Insufficiency, Heart Valve Diseases, Regurgitation, Aortic
- What is being tested?
- Quantitative aortogram (videodensitometry)
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 May 2019to Sep 2019
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with severe symptomatic aortic stenosis, requiring valve replacement.
Who may be able to join
- Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.
Who cannot join
- Patients that were not considered by the Institution's heart team as eligible
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam, 1105 AZ
Patrick W Serruys, Prof. dr., +31102062828, patrick.w.j.c.serruys@gmail.com
About this study
Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of transcatheter aortic valve replacement (TAVR)
Read the detailed description
OVAL (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab) is a single centre, prospective, proof-of-principle, feasibility study performed in the Academic Medical Centre (Amsterdam). One hundred consecutive patients with aortic stenosis and indication to undergo TAVR by the Institution's Heart team are being enrolled in OVAL. All final aortograms will be performed according to predetermined acquisition protocol and analysed immediately after the acquisition in the cath-lab. All aortograms will also be analysed off-line by an independent core laboratory in the Netherlands (Cardialysis, Rotterdam, The Netherlands).
The primary endpoint of the study is the feasibility of the on-line assessment of regurgitation (percentage of analysable cases). The secondary endpoint is the reproducibility of results between the on-line assessment and the off-line analysis by the independent core laboratory.
- Conditions
- Aortic Valve Insufficiency, Heart Valve Diseases, Regurgitation, Aortic, Paravalvular Aortic Regurgitation
- Being tested
- Quantitative aortogram (videodensitometry)
- Medical subject headings
- Aortic Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative aortogram (videodensitometry)Diagnostic test
Patients that performed TAVR will have their aortogram analysed in the cath-lab by videodensitometry (quantitative aortogram)
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online)
Feasibility of analysis (percentage of cases considered analyzable by videodensitometry - online). The investigators will assess the percentage of cases that are considered by the investigators as analyzable (i.e., that the investigators are able to perform an on-line analysis of videodensitometry).
Measured: immediately
Comparison with feasibility of ASSESS-REGURGE ( to compare the percentage of analyzable cases with the percentage of the current standard found in ASSESS-REGURGE - 95.5%)
Since ASSESS-REGURGE has the highest feasibility of analysis with quantitative aortogram, the investigators aim to compare the present feasibility (of OVAL) with the new standard from ASSESS-REGURGE. In other words, the percentage of analyzable cases in the present study will be compared with the percentage of analyzable cases found in ASSESS-REGURGE (95.5% of analyzability).
Measured: immediately
Secondary outcomes (1)
Comparison of online feasibility with core lab feasibility
The feasibility of analysis (i.e., if a cases is considered to be analyzable by videodensitometry) will be assessed on-line by the investigators and also assessed by an academic core laboratory. The result of the feasibility of analysis (percentage of analyzable cases) will be compared between the investigators assessment (on-line) and also by the core laboratory.
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start15 May 2019
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University Medical Center
- Responsible party
- Principal investigator, Patrick W. Serruys, Imperial College London
- Investigators
- Patrick W Serruys, MD, PhD, Study chair, Imperial College LondonRodrigo Modolo, MD, PhD, Principal investigator, Amsterdam University Medical CenterRobbert de Winter, MD, PhD, Principal investigator, Amsterdam University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047082
- Sponsor's protocol ID
- OVAL
- Acronym
- OVAL
- Status last verified
- Aug 2019
- First submitted
- 24 Jun 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Modolo R, van Mourik M, El Bouziani A, Kawashima H, Rosseel L, Abdelghani M, Aben JP, Slots T, Sahyoun C, Baan J, Henriques JPS, Koch KT, Vis M, Soliman O, Onuma Y, Wykrzykowska J, de Winter R, Serruys PW. Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study. JACC Cardiovasc Interv. 2021 Mar 8;14(5):531-538. doi: 10.1016/j.jcin.2020.11.014. Epub 2021 Feb 10.
PubMed 33582086
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab
- ClinicalTrials.gov ID
- NCT04047082
- Acronym / sponsor ID
- OVAL / OVAL
- Conditions
- Aortic Valve Insufficiency, Heart Valve Diseases, Regurgitation, Aortic, Paravalvular Aortic Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Amsterdam University Medical Center
- Study start
- 15 May 2019 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 6 Aug 2019 (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.
Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of transcatheter aortic valve replacement (TAVR)
Detailed description
OVAL (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab) is a single centre, prospective, proof-of-principle, feasibility study performed in the Academic Medical Centre (Amsterdam). One hundred consecutive patients with aortic stenosis and indication to undergo TAVR by the Institution's Heart team are being enrolled in OVAL. All final aortograms will be performed according to predetermined acquisition protocol and analysed immediately after the acquisition in the cath-lab. All aortograms will also be analysed off-line by an independent core laboratory in the Netherlands (Cardialysis, Rotterdam, The Netherlands).
The primary endpoint of the study is the feasibility of the on-line assessment of regurgitation (percentage of analysable cases). The secondary endpoint is the reproducibility of results between the on-line assessment and the off-line analysis by the independent core laboratory.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with severe symptomatic aortic stenosis, requiring valve replacement.
Key inclusion criteria (1 listed)
- Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.
Key exclusion criteria (1 listed)
- Patients that were not considered by the Institution's heart team as eligible
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 |
|---|---|---|
| Quantitative aortogram (videodensitometry)Patients that performed TAVR will have their aortogram analysed in the cath-lab by videodensitometry (quantitative aortogram) | Diagnostic test | – |
Primary outcome
Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online)
Time frame: immediately
Feasibility of analysis (percentage of cases considered analyzable by videodensitometry - online). The investigators will assess the percentage of cases that are considered by the investigators as analyzable (i.e., that the investigators are able to perform an on-line analysis of videodensitometry).
Comparison with feasibility of ASSESS-REGURGE ( to compare the percentage of analyzable cases with the percentage of the current standard found in ASSESS-REGURGE - 95.5%)
Time frame: immediately
Since ASSESS-REGURGE has the highest feasibility of analysis with quantitative aortogram, the investigators aim to compare the present feasibility (of OVAL) with the new standard from ASSESS-REGURGE. In other words, the percentage of analyzable cases in the present study will be compared with the percentage of analyzable cases found in ASSESS-REGURGE (95.5% of analyzability).
1 secondary outcome
Comparison of online feasibility with core lab feasibility
Time frame: immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 33582086Modolo R, van Mourik M, El Bouziani A, Kawashima H, Rosseel L, Abdelghani M, Aben JP, Slots T, Sahyoun C, Baan J, Henriques JPS, Koch KT, Vis M, Soliman O, Onuma Y, Wykrzykowska J, de Winter R, Serruys PW. Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study. JACC Cardiovasc Interv. 2021 Mar 8;14(5):531-538. doi: 10.1016/j.jcin.2020.11.014. Epub 2021 Feb 10.
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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.
Patrick W Serruys, MD, PhD study chair
Imperial College London
Rodrigo Modolo, MD, PhD principal investigator
Amsterdam University Medical Center
Robbert de Winter, MD, PhD principal investigator
Amsterdam University Medical Center
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 Aortic Valve Insufficiency and Heart Valve Diseases, run by Imperial College London at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 8 Aug 2019. 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 Netherlands. 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?
Contact Patrick W Serruys, MD, PhD (+31102062828, patrick.w.j.c.serruys@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online) (time frame: immediately). 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?
On the ClinicalTrials.gov record for NCT04047082, which also lists 1 linked publication.
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 8 Aug 2019.