A Phase 2 interventional study of Velomedix APLS device and No Hypothermia Treatment in ST-elevation MI and Hypothermia, sponsored by Velomedix, Inc.. Terminated at 7 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-07-25.
Sponsored by Velomedix, Inc. · Phase 2, Interventional, and Treatment
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.
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.
502 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's enrollment of 54 is below the median of 80 across 352 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →This is the only study on the registry with Velomedix, Inc. as lead sponsor.
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Exclusion Criteria:
Device: Velomedix APLS device
control group is no hypothermia treatment
Other: No Hypothermia Treatment
Velomedix, Automated Peritoneal Lavage System
Composite of new-onset SAEs
Composite of new-onset serious adverse events, specifically death, ischemia driven target vessel revascularization (TVR), recurrent MI, pneumonia, sepsis, ventricular tachycardia or fibrillation requiring cardioversion, renal failure, peritonitis and significant bleeding.
Time frame: 30 days
MACE rate
MACE (cardiac related mortality, recurrent MI, or ischemia driven target vessel revascularization (PCI or CABG) at 30 days
Time frame: 30 days
All cause mortality
All cause mortality through 6 months
Time frame: 6 months
Myocardial infarct size
Myocardial infarct size at 3 days post-procedure
Time frame: 3 days
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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