Clinical Trial: Synchronized Cardiac Assist for Cardiogenic Shock
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial
Brief 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.
Detailed Summary:
Sponsor: Xenios AG
Current Primary Outcome:
- Rates of device and procedure related serious adverse events [ Time Frame: 30 days ]Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.
- Technical success [ Time Frame: 24 hours ]Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).
- Device performance success [ Time Frame: 7 days ]Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Xenios AG
Dates:
Date Received: February 22, 2016
Date Started: January 2016
Date Completion: March 2018
Last Updated: March 23, 2017
Last Verified: March 2017