Clinical trial NCT04473443: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Bicuspid Cardiac Valve
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Feops
First posted: 2020-07-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This prospective multi-center international Registry of TAVI patients include for Cohort A patients with the following complex anatomy: BAV (Sievers 0 or 1) or functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots.

And for Cohort B consecutive patients eligible for TAVI with ACURATE-NEO2-valve

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 Assess the influence of FEops HEARTguideTM 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

1. Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic, Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall device success through valve size and implantation depth.
2. Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM on overall device success and PVL prediction.

Main Endpoints

1. Overall device success conform VARC-2 including need for new permanent pacemaker. 2. Incidence of \> trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker

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-NEO2-valve.

Exclusion Criteria:

* poor CT quality
* previous aortic valve replacement
* Permanent pacemaker at baseline

Primary outcomes:
measure: overall device success conform the VARC-2 document
timeFrame: 30 days after TAVI
Secondary outcomes:
measure: incidence of more than trivial PVL
timeFrame: 30 days after TAVI
measure: conduction abnormalities and need for new permanent pacemaker implantation
timeFrame: 30 days after TAVI
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas van Mieghem, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.