NCT04817735

Brief Summary

The CASPER study is a prospective, international, multicenter registry which aims to evaluate the use of an algorithm for choosing the size of the prosthesis to be implanted in patients with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29) and Evolut® R 34.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

3.5 years

First QC Date

March 23, 2021

Last Update Submit

January 27, 2025

Conditions

Bicuspid Aortic Valve

Keywords

TAVIMSCTBicuspid

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the CASPER algorithm

    The objective of the study is to validate the CASPER algorithm in a prospective cohort using a self-expandable THV, in order to assess the safety and efficacy of bicuspid aortic valve sizing based on calcium burden and raphe length.

    1 year

Secondary Outcomes (1)

  • Safety of the CASPER algorithm

    1 year

Study Arms (1)

Cohort

OTHER
Procedure: TAVI

Interventions

TAVIPROCEDURE

TAVI sizing with dedicated algorithm

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • NYHA≥2 and/or syncope and/or angina.
  • Patient judged by the Heart Team as indicated for TAVI.
  • Anatomical suitability for transfemoral or any alternative access TAVI, based on MSCT assessment and local expertise and preference.
  • Estimated life expectancy\>1 year.

You may not qualify if:

  • Age \<18 years
  • Estimated life expectancy\<1 year
  • Pure aortic regurgitation.
  • LVEF\<20%
  • No baseline MSCT evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 26, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)