Aortic Valve StenosisAVD-PowerLawNCT04600739
Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis
An observational study of Aortic Valve Stenosis, run by German Heart Institute at 1 site in Germany.
Trial summary
A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- TAVI
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 28 Oct 2019to 30 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - retrospective acquisition of patients that receive TAVI
Who may be able to join
- aortic valve stenosis
- treatment via TAVI
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzemtrum Berlin
Berlin, Deutschland, 13353
Titus Kühne, Prof. Dr., +49 30 4593 2078, titus.kuehne@dhzb.de
About this study
Official title: Entscheidungsunterstützung Bei Herzklappenerkrankungen Anhand Funktionaler Und Morphologischer Eigenschaften Mittels Methoden Der Mathematischen Modellierung Und Des Maschinellen Lernens
A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.
Read the detailed description
Using temporally resolved computed tomography images, the patient-specific geometry of the stenosed aortic valve during peak systole is reconstructed. Using this geometry, the projected area of the aortic valve's orifice (AVA) is calculated. Additionally, the left ventricular geometry is reconstructed for the complete heart cycle. Using the information of the left ventricular volume change, the patient-specific flow profile and peak-systolic flow (Q)is calculated. Using this information, the pressure gradient is calculated using a power law estimation of the form PG = a * AVA^b * Q^c. The model generation and parameter fit is described in [1].
To validate this model, retrospective data of patients receiving a catheter-based replacement of the aortic valve (TAVI) is collected. For those patients, CT images are already acquired for treatment planning and the invasive pressure measurements are performed during replacement of the aortic valve. Therefore, no additionally steps are required. Using the CT images the patient-specific aortic valve area ad flow rate are calculated. This information is then used for estimation of the pressure gradient using the power law model. The catheter-based pressure gradient is calculated as the difference between the peak-systolic pressure in the left ventricle and the ascending aorta before implantation of the prosthesis.
[1] Franke et al.; Towards improving the accuracy of aortic transvalvular pressure gradients: rethinking Bernoulli; Medical \& Biological Engineering \& Computing (2020); https://doi.org/10.1007/s11517-020-02186-w
- Conditions
- Aortic Valve Stenosis
- Being tested
- TAVI
- 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.
TAVIProcedure or surgery
Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.
| Study group | Role | What they receive |
|---|---|---|
| AVD Patients | Patients suffering from aortic valve stenosis receiving replacement of the diseased valve using a TAVI procedure. Receives: Procedure: TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
predicted vs. cather-measured pressure gradient across the aortic valv
Measured: 1 week up to 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 Oct 2020
- Study start28 Oct 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600739
- Sponsor's protocol ID
- AVD-PowerLaw
- Acronym
- AVD-PowerLaw
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 23 Oct 2020
- 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 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entscheidungsunterstützung Bei Herzklappenerkrankungen Anhand Funktionaler Und Morphologischer Eigenschaften Mittels Methoden Der Mathematischen Modellierung Und Des Maschinellen Lernens
- ClinicalTrials.gov ID
- NCT04600739
- Acronym / sponsor ID
- AVD-PowerLaw / AVD-PowerLaw
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 23 Oct 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.
A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.
Detailed description
Using temporally resolved computed tomography images, the patient-specific geometry of the stenosed aortic valve during peak systole is reconstructed. Using this geometry, the projected area of the aortic valve's orifice (AVA) is calculated. Additionally, the left ventricular geometry is reconstructed for the complete heart cycle. Using the information of the left ventricular volume change, the patient-specific flow profile and peak-systolic flow (Q)is calculated. Using this information, the pressure gradient is calculated using a power law estimation of the form PG = a * AVA^b * Q^c. The model generation and parameter fit is described in [1].
To validate this model, retrospective data of patients receiving a catheter-based replacement of the aortic valve (TAVI) is collected. For those patients, CT images are already acquired for treatment planning and the invasive pressure measurements are performed during replacement of the aortic valve. Therefore, no additionally steps are required. Using the CT images the patient-specific aortic valve area ad flow rate are calculated. This information is then used for estimation of the pressure gradient using the power law model. The catheter-based pressure gradient is calculated as the difference between the peak-systolic pressure in the left ventricle and the ascending aorta before implantation of the prosthesis.
[1] Franke et al.; Towards improving the accuracy of aortic transvalvular pressure gradients: rethinking Bernoulli; Medical \& Biological Engineering \& Computing (2020); https://doi.org/10.1007/s11517-020-02186-w
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVD Patients | – | Procedure: TAVIPatients suffering from aortic valve stenosis receiving replacement of the diseased valve using a TAVI procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - retrospective acquisition of patients that receive TAVI
Key inclusion criteria (2 listed)
- aortic valve stenosis
- treatment via TAVI
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TAVIReplacement of the aortic valve using a biological prosthesis that is inserted via a catheter. | Procedure or surgery | AVD Patients |
Primary outcome
predicted vs. cather-measured pressure gradient across the aortic valv
Time frame: 1 week up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- 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.
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 Stenosis, run by German Heart Institute 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 2 inclusion and 0 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 23 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Titus Kühne, Prof. Dr. (+49 30 4593 2078, titus.kuehne@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predicted vs. cather-measured pressure gradient across the aortic valv (time frame: 1 week up to 1 year). 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 23 Oct 2020.