Brief Title
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
Official Title
Addition of Computer Simulations to the Pre-procedural Planning to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
Brief Summary
The objective is to assess the influence of FEops HEARTguide on overall device success in
TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV)
platform selection (Cohort B).
Detailed Description
rationale:Transcatheter aortic valve implantation (TAVI) is increasingly used to treat
patients with severe aortic stenosis. However, by extending the indication for TAVI,
simulation may become increasingly important to improve procedure execution, safety and
efficacy.
objective: This study aims to assess the influence of FEops HEARTguide on overall device
success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform
selection (Cohort B).
Study design: Prospective, observational multi-center trial with 2 cohorts Study Population:
Cohort A patients with the following complex anatomy are included: BAV (Sievers 0 or 1) or
functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots.
Cohort B consecutive patients eligible for TAVI with Acurate TM and Lotus Edge TM valve
Study Procedure: Participating sites identifies cases and decide if the patient is eligible
for cohort A or B. The pre-procedural CT-scan will be uploaded to FEops HEARTguide. Heart
Team decision 1 is according to the clinical routine, including valve type and size,
pre-dilatation, post-dilatation, preferred implantation depth and comfort scale level.
Heart Team decision 2 is after the simulation of FEops HEARTguide for the final
pre-procedural planning. For Cohort A, FEops HEARTguide will give their information about
sizing and implantation depth. For Cohort B, FEops HEARTguide will give two simulations, one
with an Acurate valve and one with a Lotus Edge valve.
The operator will make the final decision about the valve selection. After the procedure the
implanted device, size and depth are recorded as standard of care. The follow-up period will
be 30 days. A new CT-scan is recommended. However, this will not be mandatory for this study.
Study Type
Observational
Primary Outcome
overall device success conform the VARC-2 document
Secondary Outcome
incidence of more than trivial PVL
Condition
Aortic Valve Stenosis
Intervention
FEops HEARTguideTM
Study Arms / Comparison Groups
Cohort A
Description: Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
200
Start Date
August 1, 2020
Completion Date
May 1, 2021
Primary Completion Date
February 1, 2021
Eligibility Criteria
Inclusion Criteria:
- Cohort A:
1. Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid
Aortic Valve
2. Patients with a severely calcified aortic valve (Agatston score > 3000 for men,
and > 1600 for women)
3. Patients with small anatomy defined by mean aortic annulus diameter < 20mm
- Cohort B:
1. every patient accepted for TAVI and eligible for Acurate TM and Lotus Edge valve
TM.
Exclusion Criteria:
- poor CT quality
- previous aortic valve replacement
- Permanent pacemaker at baseline
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nicolas van Mieghem, Md,PhD, +31107035260, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT04473443
Organization ID
PRECISE TAVI
Responsible Party
Principal Investigator
Study Sponsor
Erasmus Medical Center
Collaborators
Feops
Study Sponsor
Nicolas van Mieghem, Md,PhD, Principal Investigator, Erasmus Medical Center
Verification Date
July 2020