Aortic Valve StenosisTAVIguideNCT03196596
Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)
An observational study of Aortic Valve Stenosis, run by Erasmus Medical Center at 5 sites in 5 countries.
Trial summary
Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Computer simulation
- How many people
- 80 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 23 May 2017to 31 Jan 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 native severe aortic valve stenosis accepted for TAVI with the self-expanding Evolut R Valve by the local heart team
Who may be able to join
- Native severe aortic valve stenosis
- Planned for TAVI with the Evolut R Valve
Who cannot join
- Bicuspid aortic valve
- Extensive subannular calcifications
- Non-transfemoral access
- Poor CT quality
- Lack of written informed consent
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 CE
About this study
Official title: The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve
Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient.
The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Computer simulation
- Keywords
- TAVI, Computer simulation
- 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.
Computer simulationOther
In these patients, a computer simulation model will be obtained based on pre procedural CT
| Study group | Role | What they receive |
|---|---|---|
| Computer simulation | Patients in whom a computer simulation model will be obtained based on pre procedural CT Receives: Other: Computer simulation | |
| Prospective compare group | Patients in whom no computer simulation model will be obtained |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision 1- Valve size decision based on pre TAVI MSCT
Valve size decision based on pre TAVI Multislice Computed Tomography (MSCT), which is performed in all patients referred for TAVI in accordance to clinical routine, during the heart team meeting
Measured: an average of 2 days before TAVI, before TAVI and computer simulation
Decision 2- Valve size decision after knowledge of the computer simulation results
Valve size decision after availability of the results of computer simulation
Measured: an average of 1 day before TAVI, before TAVI but after computer simulation
Secondary outcomes (8)
Decision 3- Change of initial valve size decision during TAVI
Change of valve size decision during TAVI due to computer simulation
Measured: an average of 5 minutes after TAVI, directly after TAVI
Decision 3- Change of initial depth of implantation strategy during TAVI
Change of depth of implantation strategy during TAVI due to computer simulation
Measured: an average of 5 minutes after TAVI, directly after TAVI
Depth of implantation target
Initial depth of implantation strategy
Measured: an average of 2 days before TAVI, before TAVI and computer simulation
Depth of implantation target 2
Depth of implantation strategy after availability of computer simulation
Measured: an average of 1 day before TAVI, before TAVI but after computer simulation
Aortic regurgitation
To compare the predicted (simulation) and observed degree of aortic regurgitation (echo post TAVI - Valve Academic Research Consortium (VARC-2) criteria for aortic regurgitation)
Measured: an average of 4 days after TAVI, at hospital discharge
Correlation between predicted contact pressure and observed new conduction abnormality
To compare the predicted maximum contact pressure, contact pressure index and conduction abnormalities with the observed occurrence of new conduction abnormalities after TAVI
Measured: an average of 4 days after TAVI, at hospital discharge
MACCE
To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Measured: an average of 4 days after TAVI, at hospital discharge
Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed
To compare the clinical based valve size decision and the angiographic and echocardiographic valve performance, depth of implantation, new conduction disorders and MACCE in a prospectively collected group of patients in whom no computer simulation will be performed
Measured: an average of 4 days after TAVI, at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start23 May 2017
- Primary completion8 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Feops, Cardialysis B.V.
- Responsible party
- Principal investigator, P de Jaegere, Erasmus Medical Center
- Investigators
- Peter PT de Jaegere, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196596
- Sponsor's protocol ID
- TAVIguide
- Acronym
- TAVIguide
- Status last verified
- Feb 2019
- First submitted
- 5 Jun 2017
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schultz C, Rodriguez-Olivares R, Bosmans J, Lefevre T, De Santis G, Bruining N, Collas V, Dezutter T, Bosmans B, Rahhab Z, El Faquir N, Watanabe Y, Segers P, Verhegghe B, Chevalier B, van Mieghem N, De Beule M, Mortier P, de Jaegere P. Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve. EuroIntervention. 2016 Jan 22;11(9):1044-52. doi: 10.4244/EIJV11I9A212.
PubMed 26788707de Jaegere P, De Santis G, Rodriguez-Olivares R, Bosmans J, Bruining N, Dezutter T, Rahhab Z, El Faquir N, Collas V, Bosmans B, Verhegghe B, Ren C, Geleinse M, Schultz C, van Mieghem N, De Beule M, Mortier P. Patient-Specific Computer Modeling to Predict Aortic Regurgitation After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2016 Mar 14;9(5):508-12. doi: 10.1016/j.jcin.2016.01.003. No abstract available.
PubMed 26965945El Faquir N, Ren B, Van Mieghem NM, Bosmans J, de Jaegere PP. Patient-specific computer modelling - its role in the planning of transcatheter aortic valve implantation. Neth Heart J. 2017 Feb;25(2):100-105. doi: 10.1007/s12471-016-0923-6.
PubMed 27888494
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve
- ClinicalTrials.gov ID
- NCT03196596
- Acronym / sponsor ID
- TAVIguide / TAVIguide
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI, Computer simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Feops, Cardialysis B.V.
- Study start
- 23 May 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 23 Jun 2017 (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 is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient.
The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer simulation | – | Other: Computer simulationPatients in whom a computer simulation model will be obtained based on pre procedural CT |
| Prospective compare group | – | –Patients in whom no computer simulation model will be obtained |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with native severe aortic valve stenosis accepted for TAVI with the self-expanding Evolut R Valve by the local heart team
Key inclusion criteria (2 listed)
- Native severe aortic valve stenosis
- Planned for TAVI with the Evolut R Valve
Key exclusion criteria (5 listed)
- Bicuspid aortic valve
- Extensive subannular calcifications
- Non-transfemoral access
- Poor CT quality
- Lack of written informed consent
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 |
|---|---|---|
| Computer simulationIn these patients, a computer simulation model will be obtained based on pre procedural CT | Other | Computer simulation |
Primary outcome
Decision 1- Valve size decision based on pre TAVI MSCT
Time frame: an average of 2 days before TAVI, before TAVI and computer simulation
Valve size decision based on pre TAVI Multislice Computed Tomography (MSCT), which is performed in all patients referred for TAVI in accordance to clinical routine, during the heart team meeting
Decision 2- Valve size decision after knowledge of the computer simulation results
Time frame: an average of 1 day before TAVI, before TAVI but after computer simulation
Valve size decision after availability of the results of computer simulation
8 secondary outcomes
Decision 3- Change of initial valve size decision during TAVI
Time frame: an average of 5 minutes after TAVI, directly after TAVI
Decision 3- Change of initial depth of implantation strategy during TAVI
Time frame: an average of 5 minutes after TAVI, directly after TAVI
Depth of implantation target
Time frame: an average of 2 days before TAVI, before TAVI and computer simulation
Depth of implantation target 2
Time frame: an average of 1 day before TAVI, before TAVI but after computer simulation
Aortic regurgitation
Time frame: an average of 4 days after TAVI, at hospital discharge
Correlation between predicted contact pressure and observed new conduction abnormality
Time frame: an average of 4 days after TAVI, at hospital discharge
MACCE
Time frame: an average of 4 days after TAVI, at hospital discharge
Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed
Time frame: an average of 4 days after TAVI, at hospital discharge
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 6 Feb 2019.
- Background: PubMed 26788707Schultz C, Rodriguez-Olivares R, Bosmans J, Lefevre T, De Santis G, Bruining N, Collas V, Dezutter T, Bosmans B, Rahhab Z, El Faquir N, Watanabe Y, Segers P, Verhegghe B, Chevalier B, van Mieghem N, De Beule M, Mortier P, de Jaegere P. Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve. EuroIntervention. 2016 Jan 22;11(9):1044-52. doi: 10.4244/EIJV11I9A212.
- Background: PubMed 26965945de Jaegere P, De Santis G, Rodriguez-Olivares R, Bosmans J, Bruining N, Dezutter T, Rahhab Z, El Faquir N, Collas V, Bosmans B, Verhegghe B, Ren C, Geleinse M, Schultz C, van Mieghem N, De Beule M, Mortier P. Patient-Specific Computer Modeling to Predict Aortic Regurgitation After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2016 Mar 14;9(5):508-12. doi: 10.1016/j.jcin.2016.01.003. No abstract available.
- Background: PubMed 27888494El Faquir N, Ren B, Van Mieghem NM, Bosmans J, de Jaegere PP. Patient-specific computer modelling - its role in the planning of transcatheter aortic valve implantation. Neth Heart J. 2017 Feb;25(2):100-105. doi: 10.1007/s12471-016-0923-6.
- 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.
Peter PT de Jaegere, MD, PhD principal investigator
Erasmus Medical Center
5 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 Stenosis, run by Erasmus Medical Center at 5 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 2 inclusion and 5 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Denmark, Germany, Italy, 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?
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?
Decision 1- Valve size decision based on pre TAVI MSCT (time frame: an average of 2 days before TAVI, before TAVI and computer simulation). 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 NCT03196596, which also lists 3 linked publications.
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 6 Feb 2019.