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Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients — VELOCITY  

Hypothermia Clinical Trial

Official title:
VELOCITY: Pilot Study to Evaluate Ultrafast Hypothermia Before Reperfusion in Patients With Acute ST-Elevation Myocardial Infarction

Clinical Trial Summary

This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.

Clinical Trial Description

The study aims to determine the safety and feasibility of using the Velomedix Automated Peritoneal Lavage System to treat patients with STEMI using therapeutic hypothermia. Patients will undergo cooling, maintenance and rewarming and applicable data will be gathered on device performance and patient safety. Patient temperature and vital signs will be monitored in addition to various laboratory values. Adverse event reporting will take place at multiple time intervals and follow-up will continue out to 6-months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01655433
Study type Interventional
Source Velomedix, Inc.
Contact
Status Terminated
Phase Phase 2
Start date November 2012
Completion date March 2014
View Details
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