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

Aortic Valve Stenosis Clinical Trial

— TAVIguide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196596
• Other study ID #: TAVIguide
• Status: Completed
• Start date: May 23, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Denmark	Rigshospitalet	København
Germany	University Hospital Cologne-Heart Center	Cologne
Italy	Ospedale di San Raffaele	Milano
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Cardialysis B.V., feops

Countries where clinical trial is conducted

Belgium,  Denmark,  Germany,  Italy,  Netherlands, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

Schultz C, Rodriguez-Olivares R, Bosmans J, Lefèvre 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Decision 3- Change of initial valve size decision during TAVI	Change of valve size decision during TAVI due to computer simulation	an average of 5 minutes after TAVI, directly after TAVI
Secondary	Decision 3- Change of initial depth of implantation strategy during TAVI	Change of depth of implantation strategy during TAVI due to computer simulation	an average of 5 minutes after TAVI, directly after TAVI
Secondary	Depth of implantation target	Initial depth of implantation strategy	an average of 2 days before TAVI, before TAVI and computer simulation
Secondary	Depth of implantation target 2	Depth of implantation strategy after availability of computer simulation	an average of 1 day before TAVI, before TAVI but after computer simulation
Secondary	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)	an average of 4 days after TAVI, at hospital discharge
Secondary	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	an average of 4 days after TAVI, at hospital discharge
Secondary	MACCE	To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	an average of 4 days after TAVI, at hospital discharge
Secondary	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	an average of 4 days after TAVI, at hospital discharge