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

NCT03196596 | Completed

• 1 other identifier: TAVIguide
• Study Type: observational
• Target: 80
• Locations: 5 countries
• Sites: 5

Brief 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. 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

Keywords

TAVI; Computer simulation

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  an average of 5 minutes after TAVI, directly after TAVI

• Decision 3- Change of initial depth of implantation strategy during TAVI

  an average of 5 minutes after TAVI, directly after TAVI

• Depth of implantation target

  an average of 2 days before TAVI, before TAVI and computer simulation

• Depth of implantation target 2

  an average of 1 day before TAVI, before TAVI but after computer simulation

• Aortic regurgitation

  an average of 4 days after TAVI, at hospital discharge

Study Arms (2)

Computer simulation

Patients in whom a computer simulation model will be obtained based on pre procedural CT

Other: Computer simulation

Prospective compare group

Patients in whom no computer simulation model will be obtained

Interventions

Computer simulation OTHER

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

Computer simulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Feops: collaborator
• Cardialysis B.V.: collaborator

Study Sites (5)

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

University Hospital Cologne-Heart Center

Cologne, 50937, Germany

Location

Ospedale di San Raffaele

Milan, 20132, Italy

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 26788707 BACKGROUND

• de 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.

  PMID: 26965945 BACKGROUND

• El 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.

  PMID: 27888494 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter PT de Jaegere, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 23, 2017
• Study Start: May 23, 2017
• Primary Completion: January 8, 2019
• Study Completion: January 31, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DE (1); IT (1); NL (1); DK (1)