Summary of Clinical Research Study

Title: «Odysseus»

Rationale

The purpose of this clinical study is to evaluate the possibility of safe implantation of the PULVAD device as well as to evaluate the safe and effective assistance of patients who meet the criteria and need mechanical assistance.

Eligible candidates for the trial are patients suffering from heart failure due to idiopathic dilated cardiomyopathy (IDM) or ischemic cardiomyopathy. Data from this study will be used to draw preliminary clinical findings on the hemodynamic efficacy of the device and its potential for induction of myocardial recovery in patients with IDM or ischemic cardiomyopathy and end-stage heart failure in order to meet the criteria for LVAD implantation or as bridge to transplantation or as destination therapy.

Purpose

The evaluation of safe implantation of the PULVAD device and the evaluation of safe and effective assistance of patients who meet the criteria and need mechanical assistance.

Study population: 10 patients

Entry criteria

  1. Men or women ≥18 years old.
  2. Patients with End-Stage Heart Failure diagnosed with Idiopathic Dilated Cardiomyopathy, with left ventricular ejection fraction ≤ 35%, in the last 6 months from the evaluation visit evaluated by heart ultrasound, cardiac ventriculography or heart MRI.
  3. The patients should be classified under profile 2, 3 or 4 by ΙΝΤΕRMACS or profile 1, provided their condition is stabilized in less than 15 days of assistance with the Intra-Aortic Balloon Pump. (As stabilization under the mechanical assistance with the IABP, we mean: the no further intravenous administration of inotropes/diuretics, the absence of malfunction indications of the peripheral organs, the patient’s tolerance of the medical treatment of Heart Failure in therapeutic doses (betablockers, ACE inhibitor, ARNI, ACE inhibitors, Aldosterone antagonists), Central venous pressure ≤ 10cmH2O, Heart Rate ≤ 85 beats, Mean Blood Pressure ≥ 65mmHg).
  4. Signed consent form of the patient’s participation in the study, after informing and accepting to comply with its requirements.

 

Exclusion Criteria

  1. Severe valvular aortic failure, failure 2+ with echocardiography or aortic valve stenosis, with valve surface ≤1.5 cm2
  2. Active Infection
  3. Aneurysm or severe asbestosis of the ascending aorta
  4. Renal failure caused by chronic Heart Failure (serum creatinine > 3.5mg/dL)
  5. Serum bilirubin >5%mm/dL, which is unresponsive to the medical treatment with inotropes or the IABP
  6. Non restorable coagulation disorders
  7. Uncontrollable atrial or ventricular arrhythmias (HR > 100 beats)
  8. Severe Pulmonary Disease
  9. Severe Carotid Occlusive Disease
  10. Heart Rate > 2.2L/min/m2 with pulmonary capillary wedge pressure < 15mmHg
  11. History or presence of other disease (e.g. malignity) with less than a year life expectancy
  12. Participation in an interventional study with investigational drug or medical device within the previous month
  13. Any surgical or medical condition, that according to the investigator’s judgment, could jeopardize the assessment of the efficacy / safety of the implantation/ removal of the  PULVAD
  14. History of unreliable compliance with previous treatment or unreliable patients
  15. Pregnant or lactating females.