CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
4D Cardiac CT Scan +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03200574
NCT03200574N/ACompleted
CompareCT.gov

Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant

Corcym S.r.l·interventional·Posted Jun 27, 2017·Updated Mar 6, 2024

In Brief

A clinical study evaluating 4D Cardiac CT Scan and LivaNova Bioprothetic Aortic Valve Implant for Aortic-valve Replacement. Completed, enrolled 88 participants across 11 sites in 2 countries.

Detailed Summary

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic-valve Replacement
CountriesCanada, United States
CollaboratorsLivaNova

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 27, 2017
Enrollment StartDec 6, 2017
Primary CompletionJun 15, 2020
Study CompletionFeb 25, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.0 years ago

Interventions

4D Cardiac CT Scanother

4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy

LivaNova Bioprothetic Aortic Valve Implantdevice

Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.