Clinical Trials

The Freedom® Driver System

SynCardia is conducting an FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom®driver system, the first-ever U.S. portable driver designed to power the SynCardia temporary Total Artificial Heart inside and outside the hospital.

Background:

Currently, the only FDA-approved driver for powering the Total Artificial Heart in the U.S. is the 418-lb hospital driver nicknamed “Big Blue”. Stable Total Artificial Heart patients in the U.S. supported by this driver are confined to the hospital while they wait for a matching donor heart. These patients wait an average of 144 days until they receive their transplant.

Through the IDE clinical study, stable Total Artificial Heart patients who meet study criteria may have the option to be discharged from the hospital with the Freedom portable driver, to wait for their matching donor heart at home and in their communities.

IDE Clinical Study: click images on the right to enlarge ››

Primary Outcome Measures:

The Freedom driver is a suitable pneumatic driver for stable
Total Artificial Heart patients.
The Freedom driver can be safely used at home.

Estimated Enrollment: The trial may enroll 60 patients at up to 30 institutions. 30 of these patients must be discharged home.

Endpoints:

Heart transplant
90 days of Freedom driver support, at home or in the hospital
Death

Criteria:

Inclusion Criteria:

The Total Artificial Heart with the Freedom driver is indicated for use as a bridge to cardiac transplant in clinically stable cardiac transplant-eligible candidates who are implanted with the Total Artificial Heart.

Exclusion Criteria:

Patients who are not cardiac transplant-eligible.
Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas <1.7m2, or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) <10cm.
Patients who cannot be adequately anticoagulated on the Total Artificial Heart.

Driver Features:

The Freedom driver weighs 13.5 lbs including two onboard batteries and a power adaptor.
The batteries are designed to be charged using a standard electrical outlet or car charger.
The driver is designed to be carried by the patient in the Freedom Backpack or Shoulder Bag.
The Freedom driver uses a “dark cockpit” design, meaning the driver only flashes a light and sounds an alarm when something requires the user’s attention.
The Freedom driver is intended to be serviced by replacement via express delivery.
No onsite repair or inventory of parts is required by the hospital.

Trial Update: Enrollment and Patient Discharges

As of Jan. 3, 2012, 35 Total Artificial Heart patients have been enrolled in the clinical study. Of these patients, 23 have been discharged from the hospital using the Freedom portable driver.