BioVentrix Revivent TC™ System Clinical Study

The Revivent TC System is indicated for patients referred for surgical treatment of left
ventricular scar that is contiguous, and includes both anterior and septal components.
Primary and Secondary Effectiveness Endpoints will compare data from the patients treated
with the Revivent TC System to a control pool of patients who comply with all aspects of the
protocol except scar location and are not treated with the investigational devices but remain
on Guideline Directed Medical Therapy (GDMT). The primary safety and effectiveness endpoints
will be evaluated at 12 months post procedure. The study will be conducted at a maximum of 20
clinical centers.

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