Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI) (TAVIguide)

February 5, 2019 updated by: P de Jaegere, Erasmus Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
  • Denmark
      • København, Denmark, 2100
        • Rigshospitalet
  • Germany
      • Cologne, Germany, 50937
        • University Hospital Cologne-Heart Center
  • Italy
      • Milano, Italy, 20132
        • Ospedale di San Raffaele
  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 CE
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with native severe aortic valve stenosis accepted for TAVI with the self-expanding Evolut R Valve by the local heart team

Description

Inclusion Criteria:

  • Native severe aortic valve stenosis
  • Planned for TAVI with the Evolut R Valve

Exclusion Criteria:

  • Bicuspid aortic valve
  • Extensive subannular calcifications
  • Non-transfemoral access
  • Poor CT quality
  • Lack of written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Computer simulation
Patients in whom a computer simulation model will be obtained based on pre procedural CT
Other: Computer simulation
In these patients, 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
an average of 2 days before TAVI, before TAVI and computer simulation
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
an average of 1 day before TAVI, before TAVI but after computer simulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decision 3- Change of initial valve size decision during TAVI
Time Frame: an average of 5 minutes after TAVI, directly after TAVI
Change of valve size decision during TAVI due to computer simulation
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
Change of depth of implantation strategy during TAVI due to computer simulation
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
Initial depth of implantation strategy
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
Depth of implantation strategy after availability of computer simulation
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
To compare the predicted (simulation) and observed degree of aortic regurgitation (echo post TAVI - Valve Academic Research Consortium (VARC-2) criteria for aortic regurgitation)
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
To compare the predicted maximum contact pressure, contact pressure index and conduction abnormalities with the observed occurrence of new conduction abnormalities after TAVI
an average of 4 days after TAVI, at hospital discharge
MACCE
Time Frame: an average of 4 days after TAVI, at hospital discharge
To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
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
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
an average of 4 days after TAVI, at hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardialysis B.V.
Feops

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter PT de Jaegere, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAVIguide

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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