Last updated on July 2019

BioVentrix Revivent TC System Clinical Study

Are you eligible to participate in this study?

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

  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • LV Aneurysm Scar Presence: Defined by a contiguous acontractile (akinetic and/or dyskinetic) scar
  • LV Aneurysm Scar Location: Defined as a scar involving septum and anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management;
  • Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging;
  • Left Ventricular Ejection Fraction <45%.
  • Left ventricular end-systolic volume index 50 mL/m2
  • Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy;
  • Patient completed 6 Minute Walk Test and MLHF Quality of Life Questionnaire
  • Patient is on adequate Guideline Directed Medical Therapy (GDMT)
  • Subject or a legally authorized representative must provide written informed consent;
  • Agree to required follow-up visits; and
  • Female subject of childbearing potential does not plan pregnancy for at least one year following the index procedure. For a female of childbearing potential, a pregnancy test must be performed with negative results known within seven days prior to index procedure

Candidates for the study group must meet ALL of the inclusion criteria.

Candidates allocated to active concurrent control group must meet all inclusion criteria (including LV Aneurysm Scar Presence), WITH THE EXCEPTION OF LV Aneurysm Scar Location.

Exclusion Criteria:

Candidates will be excluded from the study and active concurrent control group if ANY of the following conditions are present:

  • Calcified ventricular wall in the area of intended anchor implants as verified by cardiac imaging;
  • Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by cardiac imaging;
  • Cardiac Resynchronization Therapy (CRT) device placement 60 days prior to enrollment;
  • Valvular heart disease, which in the opinion of the investigator, will require surgery;
  • Functional Mitral Regurgitation greater than moderate (i.e. EROA>20mm sq.) and degenerative MR (including MR due to papillary muscle rupture);
  • Need for coronary revascularization, in the opinion of the site investigator;
  • Contraindication or inability to adhere to systemic anticoagulation;
  • Peak Systolic Pulmonary Arterial Pressure > 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale;
  • Myocardial Infarction within 90 days prior to enrollment;
  • Prior CVA or TIA within the last six months, or any prior intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology;
  • Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission;
  • Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac;
  • Chronic renal failure with a serum creatinine >2.5 mg/dL and/or GFR<30ml/min;
  • Pulmonary disease that would preclude single lung ventilation;
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
  • Known hypersensitivity or contraindication to device materials;
  • Previous pericardiotomy or left thoracotomy;
  • Pathology/previous surgery/radiation therapy of the right neck;
  • Prior open heart surgery or significant pericarditis; or
  • Presence of significant ventricular arrhythmias

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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