CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
i-cor Synchronized Cardiac Assist Devicedevice
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/NCT02697006
NCT02697006N/ACompleted

Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial

Xenios AG·observational·Posted Mar 2, 2016·Updated Sep 16, 2022

In Brief

An observational study evaluating i-cor Synchronized Cardiac Assist Device for Shock, Cardiogenic and High Risk Percutaneous Coronary Interventions. Completed, enrolled 47 participants across 1 site.

Detailed Summary

The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
CollaboratorsAvania

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2, 2016
Enrollment StartJan 1, 2016
Primary CompletionApr 30, 2018
Study CompletionFeb 16, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.3 years ago

Interventions

i-cor Synchronized Cardiac Assist Devicedevice

The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.