Mechanical Circulatory Support

Cedars-Sinai Heart Institute is currently conducting the following Mechanical Circulatory Support trials:

 

 

SynCardia Freedom Driver System Study

IRB Approval No.: 24378

Status: Enrolling

Contact: Charito Olay, VAD Coordinator, (310) 423-7338

Project Summary: On 15 October 2004, the SynCardia temporary Total Artificial Heart (TAH-t) received FDA approval (Premarket Approval Application [PMA] #P030011) for in-hospital use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. The implantable TAH-t is powered by an external pneumatic driver, the Circulatory Support System (CSS) Console. Because the size and weight of the CSS Console limit the mobility of TAH-t patients, SynCardia developed a smaller, portable external pneumatic driver, the Freedom Driver System, which incorporates some of the CSS Console operating parameters to provide the pneumatic support required by the implanted TAH-t in clinically stable patients, while enhancing their mobility. Design verification test results demonstrate that the Freedom Driver operates within the specifications of the CSS Console to provide the pulsatile pneumatic pressures required to support clinically stable TAH-t patients safely in and out of the hospital. This clinical study is intended to:

  • Confirm the design verification test results that demonstrated that the Freedom Driver is a suitable pneumatic driver for clinically stable TAH-t patients and
  • Confirm that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.

 

The Medical Arm of Mechanical Circulatory Support (MedaMACS) Study

IRB Approval No.: 31257

Status: Enrolling

Contact: Maria Thottam, Study Coordinator, (310) 248-7132

Project Summary: Despite widespread use of evidence‐based medical therapies, mortality and morbidity from systolic heart failure remain high. Breakthroughs in the mechanic circulatory support technology have extended survival and improved quality in advanced heart failure patients awaiting cardiac transplantation and in inotrope-dependent patients who are eligible for heart transplant. The INTERMACS Registry has facilitated the refinement of patient selection for this therapy by analysis of those patients who have received devices. Integral to the original intent of INTERMACS was comparison to ambulatory patients living with advanced heart failure who were not currently receiving mechanical circulatory support devices. MedaMACS will characterize the types of patients who are not receiving an LVAD currently due to the intersection of relative contraindications, to their own preferences, or to their characterization as "less sick" either by perception or by absolute criteria as currently defined for lifetime VAD support. This will be a prospective, observational study of ambulatory patients with advanced heart failure. Study activities include Baseline A (at consent), Baseline B (3‐6 weeks following consent), 6 month telephone call, 12 month follow‐up, 18 month telephone call, and 24 month follow‐up. Researchers will collect data from 6 minute walk tests, medical records, and questionnaires/surveys. CSMC anticipates enrolling approximately 30 subjects.

 

Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP)

IRB Approval No.:

Status: Enrollment Closed

Contact: Maria Thottam, Study Coordinator, (310) 248-7132

Project Summary: The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus OMM in ambulatory NYHA Class IIIB/IV HF patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.

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