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NCT Number: NCT03196596

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer simulation

Other

In these patients, a computer simulation model will be obtained based on pre procedural CT

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Depth of implantation target

    Time frame: an average of 2 days before TAVI, before TAVI and computer simulation

    Initial depth of implantation strategy

  4. 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

  5. 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)

  6. 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

  7. 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)

  8. 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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Cardialysis B.V.
  • Feops

Registry information

Official study title

The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve

Acronym: TAVIguide

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2017
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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