ALIVE-EA Clinical Study

Conditions: Symptomatic Heart Failure of Left Ventricular Antero Septal Aneurysms or Scars That Are Contiguous and Includes Both Anterior and Septal Components

Summary

Eligibility Criteria

Inclusion Criteria:18 years old or older;LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar;LV Aneurysm/Scar Location: Defined as a scar involving septum and/or 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 (can be performed at baseline visit);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; andFemale 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.Exclusion Criteria:Cardiac Resynchronization Therapy (CRT) or ICD pacing lead 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 primary MR (including MR due to papillary muscle rupture);Need for coronary revascularization, in the opinion of the site investigator;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;Within the last six months, a prior CVA or TIA, or any 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; Page 6 of 64 BioVentrix CIP-0067, Rev AChronic renal failure with a serum creatinine >2.5 mg/dL and/or GFR<30ml/min;Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.Presence of significant ventricular arrhythmiasContraindication or inability to adhere to systemic anticoagulation;Known hypersensitivity or contraindication to device materials;Previous pericardiotomy or left thoracotomy;Pathology/previous surgery/radiation therapy of the right neck that would interfere with placement of a 14F delivery catheter;Prior open heart surgery or significant pericarditis;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 that has not been adequately treated with anticoagulant.Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement.

Source: ClinicalTrials.gov (NCT05710042). StuddyBuddy aggregates publicly available trial information.