Ventricular Partitioning Device: EU “Real World” Study Commences

In short

CardioKinetix Inc., a pioneering in catheter-based treatment for heart failure, announced today that it has begun enrollment in PARACHUTE III, a post-market safety surveillance trial, in Germany with the CE Marked Parachute™ Ventricular Partitioning Device.

Background

A few weeks ago we covered the story of CardioKinetix’s Parachute Ventricular Partitioning Device and the favourable study data being presented at EuroPCR at the time. That item can be found here.

Now the company has issued a press release announcing the commencement of enrollment into a new study, labelled PARACHUTE III.

As a reminder, the Parachute device offers the first minimally-invasive catheter-based treatment to partition enlarged sections of the left ventricle in heart failure patients, thereby excluding the non-functional heart segment from the healthy, functional segment, effectively decreasing the overall volume of the left ventricle and restoring its geometry and function.

Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle. This minimally invasive procedure is performed in the catheterisation laboratory under conscious sedation.

The PARACHUTE III study

PARACHUTE III is a dual-arm (Parachute vs. optimal medical therapy), open-label, multi-centre trial, designed to evaluate the Parachute implant in a real-world setting. The trial will enroll up to 100 patients with ischemic heart failure at up to 20 centers in Europe. The primary endpoint of the trial is procedural- and device-related Major Adverse Cardiac Events (MACE) through 60 months. Other key endpoints include haemodynamic measures by echocardiography and imaging measures by computed tomography (CT).

The first implants with CE Marked Parachute devices were done in Heidelberg, Germany by Stefan Hardt, M.D., Department of Cardiology, Heidelberg University Clinic as part of the PARACHUTE III trial, which is designed to evaluate the long-term safety of the Parachute implant in a real-world setting in up to 100 patients with ischemic heart failure at up to 20 centres in Europe. Professor Hardt reported that all patients were treated successfully and discharged without procedure-related complications. A successful case was also performed by Heyder Omran, M.D., Ph.D., Department of Cardiology and internal Medicine, St. Marien-Hospital Abt. Innere Medizin in Bonn, Germany.

Clinician comments

“The Parachute implant system represents an important advancement in treatment options for patients with ischemic heart failure,” said Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England, and the principle investigator for the PARACHUTE III study. “These first procedures in the PARACHUTE III trial represent the beginning of the largest clinical data evaluation for this new therapy to date. I am optimistic that the patients treated with the Parachute implant will experience positive results similar to those in prior trials of the device most recently reported during the 2012 EuroPCR meeting.”

Regulatory status

The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.

Source: CardioKinetix Inc., Business Wire