Clinical Trials

VELOCITY Clinical Trial

The VELOCITY Trial is a sixty patient randomized pilot trial (1:1) to evaluate the Velomedix Automated Peritoneal Lavage System in patients with ST-segment elevation myocardial infarction (STEMI), presenting within six hours of symptom onset. The trial will investigate the safety and feasibility of augmenting today’s standard of care (primary Percutaneous Coronary Intervention) with therapeutic hypothermia delivered by the Velomedix system. The FDA has granted approval for up to nine US sites and Health Canada has granted approval for up to four Canadian sites.

The study’s primary endpoint is a composite of specific new-onset, serious adverse events (SAE) at thirty days. Several secondary endpoints will be also recorded, including infarct size, myocardial salvage, and left ventricular ejection fraction (LVEF). Thus, while a safety trial, VELOCITY will also gather meaningful efficacy information.

The co-principal investigators for this study are Gregg Stone, MD of Columbia University Medical Center / New York-Presbyterian Hospital and Graham Nichol, MD of the University of Washington — Harborview Center for Prehospital Emergency Care. The trial began actively recruiting in December, 2012.

For more information on the VELOCITY Trial, www.clinicaltrials.gov, NCT01655433.

 

Completed Clinical Trials

The Velomedix system has been studied in three previous clinical trials outside the U.S. and enrolled a total of sixty-three patients. Each trial investigated the safety and feasibility of inducing mild hypothermia with the Velomedix system in a specific patient group (for individual trial descriptions, see below).

In these three trials, the Velomedix system demonstrated safe and rapid induction of mild hypothermia in the three trials of sixty-three patients, approximately half of which underwent PCI and/or stenting. Peritoneal access and catheter placement was easily and safely achieved. Desired temperatures were reached in an average time of less than fifteen minutes. Patients tolerated the procedure well, shivering was managed, and there were no serious bleeding events. The system was safely and easily employed to induce mild hypothermia without interfering with PCI/stenting procedures and without any device-related serious adverse events.

As a result of these positive trial results, Velomedix embarked on the VELOCITY Trial (www.clinicaltrials.gov, NCT01655433), a sixty patient North American randomized pilot trial to investigate the safety and feasibility of inducing therapeutic hypothermia in patients undergoing PCI and stenting for anterior ST-segment elevation myocardial infarction (STEMI), presenting within six hours of symptom onset. See VELOCITY Clinical Trial section above for more information.

 

Individual Completed Trials

CAMARO Trial

  • Forty-nine patient, prospective, multi-center trial with two subgroups to assess the safety and feasibility of 1) inducing mild hypothermia to improve neurologic outcome in subjects experiencing cardiac arrest (CA) following the return of spontaneous circulation (ROSC), and 2) inducing mild hypothermia in subjects suffering from STEMI to reduce infarct size

CIN Prevention Trial

  • Nine patient, prospective, single-center, single-arm clinical trial designed to assess the safety of inducing mild hypothermia prior to routine PCI procedures as a means of reducing contrast-induced nephropathy (CIN) in subjects with compromised renal function (i.e. at high risk for CIN)

Initial Human Clinical Trial

  • Five patient, prospective, multi-center, single arm clinical trial to assess the feasibility and safety of whole body cooling of organ donor subjects to achieve early and complete organ hypothermia prior to procurement thereby potentially reducing ischemia / reperfusion injury of the donated organs