Aortic Valve InsufficiencyASSESS-REGURGENCT03644784
Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.
An observational study of Aortic Valve Insufficiency and Aortic Valve Regurgitation, run by Imperial College London at 6 sites in 5 countries.
Trial summary
The ASSESS-REGURGE is a multicenter, multicontinental registry on protocoled aortographic image acquisition after implantation of a transcatheter aortic valve. After the implementation of the acquisition protocol, each participating site will use the standardized approach for their center in order to identify if the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Insufficiency, Aortic Valve Regurgitation
- What is being tested?
- Standardized protocol for assessing aortic regurgitation using videodensitometry
- How many people
- 354 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Sep 2017to 31 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic regurgitation that are undergoing TAVR in the 5 centers
Who may be able to join
- Eligible and undergoing TAVR procedure
Who cannot join
- Considered not eligible for TAVR procedure by the local Heart Team
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Netherlands2 sites
Academic Medical Center
Amsterdam
Erasmus Medical Center
Rotterdam
About this study
The ASSESS-REGURGE is a multicenter, multicontinental registry on protocoled aortographic image acquisition after implantation of a transcatheter aortic valve. After the implementation of the acquisition protocol, each participating site will use the standardized approach for their center in order to identify if the images are considered analyzable via videodensitometry quantitative assessment of aortic regurgitation.
- Being tested
- Standardized protocol for assessing aortic regurgitation using videodensitometry
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized protocol for assessing aortic regurgitation using videodensitometryDiagnostic test
Standardized protocol for assessing aortic regurgitation using videodensitometry
| Study group | Role | What they receive |
|---|---|---|
| Yamaguchi University Hospital | Not described Receives: Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry | |
| Erasmus Medical Center | Not described Receives: Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry | |
| Academic Medical Center - Amsterdam | Not described Receives: Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry | |
| Segeberger Kliniken Gruppe | Not described Receives: Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry | |
| McGill University - Montreal | Not described Receives: Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (percentage of the cases considered analyzable) of analysis of aortic regurgitation from aortograms using the videodensitometry technique
Measurement of feasibility, i.e. the percentage of the number of cases, out of the entire sample size that are considered to be analyzable for quantitative aortic regurgitation assessment using videodensitometry after the implementation of the acquisition protocol. Since the analyzability of the aortic regurgitation from the aortograms depends in some acquisition factors, we will assess the feasibility of analysis after implantation of acquisition protocols.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Sep 2017
- Primary completion1 Mar 2019
- Study completion31 Mar 2019
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
- Other
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Yamaguchi University Hospital, Segeberger Kliniken GmbH, McGill University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus 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, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Yoshinobu Onuma, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644784
- Sponsor's protocol ID
- ASSESS-REGURGE
- Acronym
- ASSESS-REGURGE
- Status last verified
- Aug 2019
- First submitted
- 1 Mar 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Modolo R, Chang CC, Tateishi H, Miyazaki Y, Pighi M, Abdelghani M, Roos MA, Wolff Q, Wykrzykowska JJ, de Winter RJ, Piazza N, Richardt G, Abdel-Wahab M, Soliman OII, Onuma Y, Van Mieghem NM, Serruys PW. Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry. EuroIntervention. 2019 Aug 29;15(5):420-426. doi: 10.4244/EIJ-D-19-00362.
PubMed 31147307
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.
- ClinicalTrials.gov ID
- NCT03644784
- Acronym / sponsor ID
- ASSESS-REGURGE / ASSESS-REGURGE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Yamaguchi University Hospital, Segeberger Kliniken GmbH, McGill University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Aug 2018 (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.
The ASSESS-REGURGE is a multicenter, multicontinental registry on protocoled aortographic image acquisition after implantation of a transcatheter aortic valve. After the implementation of the acquisition protocol, each participating site will use the standardized approach for their center in order to identify if the images are considered analyzable via videodensitometry quantitative assessment of aortic regurgitation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Yamaguchi University Hospital | – | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry |
| Erasmus Medical Center | – | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry |
| Academic Medical Center - Amsterdam | – | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry |
| Segeberger Kliniken Gruppe | – | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry |
| McGill University - Montreal | – | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic regurgitation that are undergoing TAVR in the 5 centers
Key inclusion criteria (1 listed)
- Eligible and undergoing TAVR procedure
Key exclusion criteria (1 listed)
- Considered not eligible for TAVR procedure by the local Heart Team
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 |
|---|---|---|
| Standardized protocol for assessing aortic regurgitation using videodensitometryStandardized protocol for assessing aortic regurgitation using videodensitometry | Diagnostic test | Academic Medical Center - Amsterdam, Erasmus Medical Center, McGill University - Montreal, Segeberger Kliniken Gruppe, Yamaguchi University Hospital |
Primary outcome
Feasibility (percentage of the cases considered analyzable) of analysis of aortic regurgitation from aortograms using the videodensitometry technique
Time frame: 1 year
Measurement of feasibility, i.e. the percentage of the number of cases, out of the entire sample size that are considered to be analyzable for quantitative aortic regurgitation assessment using videodensitometry after the implementation of the acquisition protocol. Since the analyzability of the aortic regurgitation from the aortograms depends in some acquisition factors, we will assess the feasibility of analysis after implantation of acquisition protocols.
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 7 Aug 2019.
- Results publication: PubMed 31147307Modolo R, Chang CC, Tateishi H, Miyazaki Y, Pighi M, Abdelghani M, Roos MA, Wolff Q, Wykrzykowska JJ, de Winter RJ, Piazza N, Richardt G, Abdel-Wahab M, Soliman OII, Onuma Y, Van Mieghem NM, Serruys PW. Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry. EuroIntervention. 2019 Aug 29;15(5):420-426. doi: 10.4244/EIJ-D-19-00362.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Insufficiency
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruiting
J-Valve Transfemoral Pivotal Study
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
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 principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Yoshinobu Onuma, MD, PhD principal investigator
Erasmus Medical Center
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Insufficiency and Aortic Valve Regurgitation, run by Imperial College London at 6 sites in 5 countries.
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 7 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 6 sites in Netherlands, Canada, Germany, Japan, United Kingdom. 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?
Feasibility (percentage of the cases considered analyzable) of analysis of aortic regurgitation from aortograms using the videodensitometry technique (time frame: 1 year). 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 NCT03644784, 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 7 Aug 2019.