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Synchronized Cardiac Assist for Cardiogenic Shock

NCT02697006 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2022-09-16

Study results available
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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

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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Xenios AG

    lead INDUSTRY

Principal Investigators

  • Christoph Liebetrau, Dr. med. · Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-04-30
Completion
2019-02-16

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02697006 on ClinicalTrials.gov