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