Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

— PRECISE_TAVI  

Official title:

Addition of Computer Simulations to the Pre-procedural Planning to Minimize Adverse Events After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04473443
• Other study ID #: PRECISE TAVI
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: Nicolas van Mieghem, MD, PhD
• Phone: +31107035260
• Email: n.vanmieghem[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bicuspid Cardiac Valve

Intervention

Other:
• FEops HEARTguideTM
A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Feops

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Kappetein AP, Head SJ, Généreux 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, Rodés-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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall device success conform the VARC-2 document	Incidence of mortality; incidence of stroke; incidence of major vascular complication; incidence of life-threatening bleeding	30 days after TAVI
Secondary	incidence of more than trivial PVL	total incidence of trivial PVL	30 days after TAVI
Secondary	conduction abnormalities and need for new permanent pacemaker implantation	incidence of new permanent pacemaker implantations; incidence of left bundle branch block; incidence of total AV block	30 days after TAVI