The DRAIN-HF study evaluates the Aortix percutaneous mechanical circulatory support (pMCS) technology. Patients in the trial present acute decompensated heart failure (ADHF) and remain unresponsive to standard medical therapy.
Dr. Bassem Chehab enrolled the first patient at the Ascension Via Christi Hospital in Manhattan, Kansas.
“I am thrilled to enroll the first patient in this important trial,” Chehab said in a news release. “Today, there are no effective treatment options for patients with ADHF who remain congested despite being treated with high-dose intravenous diuretic therapy. These patients have very poor outcomes in terms of death and rehospitalization and therefore new therapy options are critically needed.”
The study also includes a registry for advanced heart failure patients considered end-stage and not surgical candidates for heart transplant or LVAD implant due to excessive fluid retention and poor kidney function. Dr. Gillian Grafton enrolled the first patient at Henry Ford Hospital in Detroit.
“The Aortix pump demonstrated promising results to help off-load fluid and improve kidney function. I am excited to be able to include the advanced heart failure patients in the trial,” said Grafton.
More about the Procyrion Aortix system and DRAIN-HF trial
Aortix, a catheter-deployed pump, goes in the descending thoracic aorta. Procyrion designed it to directly unload the heart and improve cardiac performance while increasing perfusion to the kidneys.
A previous pilot study demonstrated rapid decongestion with substantial removal of excess fluid and improved hemodynamics. Patients also showed improvements in kidney function, cardiac function and shortness of breath with Aortix. Procyrion presented results from this study in March of this year.
DRAIN-HF evaluates the safety and effectiveness of Aortix compared to standard of care, which includes high-dose IV diuretics. Procyrion plans to enroll up to 268 patients across 45 U.S. centers. The study will include a randomized arm and a registry arm for patients targeted for a heart transplant or LVAD. These patients are too sick for surgery.
“The initiation of the DRAIN-HF pivotal study represents a major milestone in the company’s commitment to make Aortix available for these acutely decompensated heart failure patients who have failed aggressive standard of care medical therapies,” said Dr. Eric S. Fain, president and CEO, Procyrion. “We look forward to working with our investigators and research teams to advance the scientific evidence around this groundbreaking technology.”
