St. Francis Hospital participates in unique heart recovery clinical trial

INDIANAPOLIS – Heart attack patients and others with coronary conditions may benefit from a catheter-based pump device being evaluated in a clinical trial now under way at St. Francis Hospital & Health Centers.

The device is the Impella 2.5, developed by the Massachusetts-based Abiomed Inc. St. Francis is one of the few medical facilities to participate in the PROTECT II trial, the second Food and Drug Administration-approved trial for prophylactic preventive use of the device during non-emergent high-risk coronary intervention procedures.

“We are please to participate in the pivotal PROTECT II trial and we look forward to improving the treatment of high-risk patients,” said principal investigator William J. Berg, M.D., of the Indiana Heart Physicians and St. Francis Heart Center. “The Impella offers physicians a minimally invasive breakthrough technology in cardiac treatment and we’re excited to further demonstrate its effectiveness in this secondary trial.”

The current trial follows Abiomed’s previous PROTECT I trial, which yielded successful results for the ease-of-use and safety of the device, according to company officials.

The Impella 2.5, the world's smallest ventricular assist device (VAD), provides patients with up to 2.5 liters of blood flow per minute. It’s been used to treat more than 1,000 patients in Europe who have had heart attacks and cardiogenic shock, a condition in which a weakened heart cannot pump enough blood to meet the body’s needs.

The trial was approved earlier this year by institutional review board, which oversees all clinical investigations conducted at St. Francis Hospital & Health Centers.

To be eligible for the study, patients must have a left main lesion, only one remaining vessel open, or have triple vessel disease. They also must have a low ejection fraction (below 30 percent or 35 percent, depending on their other qualifying traits).

For more information about the trial, contact Kathy Lawson at 317-851-2582.

More details about the Abiomed’s Impella 2.5 device can be found at www.abiomed.com/products/impella.cfm.

The St. Francis Heart Center is a state-of-the-art facility and the only full-service cardiac and vascular care program on Indianapolis’ south side. For more information about its services go to www.stfrancishospitals.org/Heart.

Editors/Reporters: Still images and DVD B-roll are available