Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Acute Myocardial Infarction
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The overall objective of this randomized trial is to evaluate the Safety and Efficacy of intravascular cooling using the ZOLL Thermogard XP3 IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction and undergoing PCI. The objective of the Phase A trial ...

The overall objective of this randomized trial is to evaluate the Safety and Efficacy of intravascular cooling using the ZOLL Thermogard XP3 IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction and undergoing PCI. The objective of the Phase A trial is to demonstrate successful incorporation of intravascular cooling into US standard of care.

Tracking Information

NCT #
NCT03361995
Collaborators
Not Provided
Investigators
Not Provided