NCT02697006

Synchronized Cardiac Assist for Cardiogenic Shock

Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Xenios AG · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shock, Cardiogenic
• High Risk Percutaneous Coronary Interventions

Interventions

Type	Name	Description
DEVICE	i-cor Synchronized Cardiac Assist Device	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-04-30
• Completion: 2019-02-16
• First posted: 2016-03-02
• Last updated: 2022-09-16
• Results posted: 2022-09-16

Locations

1 site across 1 country: Germany