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

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.