Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients (VELOCITY)

Velomedix

Status and phase

Terminated

Phase 2

Conditions

ST-elevation MI

Hypothermia

Treatments

Other: No Hypothermia Treatment

Device: Velomedix APLS device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01655433

VMXP-2490

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical symptoms consistent with acute STEMI lasting at least 30 minutes
STEMI with ST-Elevation of ≥2 mm in two or more contiguous ECG leads
Patient eligible for PCI

Exclusion criteria

Cardiac arrest with return of spontaneous circulation
Known prior history of MI
Known history of severe COPD requiring supplemental home oxygen
Patient experiencing intractable cardiogenic shock, or requiring immediate placement of a mechanical cardiac assist device
Known severe anemia or abnormal platelet count
Known significant renal insufficiency
Known contraindication for MRI
Known contraindications to hypothermia, such as temperature-sensitive hematological dyscrasias or vasospastic disorders