Last updated on July 2019

REDUCER-I: An Observational Study of the Neovasc Reducer System

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Stable Angina | Angina Pectoris | Stable
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria - ALL Arms:

  • Subject has been informed about the study and provides written informed consent prior to enrollment
  • Subject is willing to comply with specified follow-up evaluations

Inclusion Criteria - Arm 1:

  • Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy
  • Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI)
  • Evidence of reversible myocardial ischemia
  • Left Ventricular ejection fraction (LVEF) greater than or equal to 30%
  • Male or non-pregnant female

Inclusion Criteria - Arm 2:

  • Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study

Inclusion Criteria - Arm 3:

  • Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study

Exclusion Criteria - Arm 1:

  • Recent (within three months) acute coronary syndrome
  • Recent (within six months) PCI or CABG
  • Unstable angina during the 30 days prior to baseline
  • Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to baseline
  • Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and / or pacemaker
  • Severe chronic obstructive pulmonary disease (COPD)
  • Subject cannot undergo exercise tolerance test or 6-minute walk test for reasons other than refractory angina
  • Severe valvular heart disease
  • Subject with pacemaker or defibrillator electrode in the right atrium (RA), right ventricle (RV), or Coronary Sinus (CS)
  • Subject having undergone tricuspid valve replacement or repair
  • Chronic renal failure including subjects on chronic hemodialysis
  • Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year
  • Known allergy to stainless steel or nickel
  • Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints

Angiographic Exclusion:

  • Mean right atrial pressure greater than or equal to 15mmHg
  • Subject with anomalous or abnormal CS as demonstrated by angiogram

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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