Patient Identification
Patient characteristics suitable for consideration of the V-Wave™ Ventura Interatrial Shunt
- LVEF ≤40%
- 18 years of age or older
- Documented diagnosis of heart failure for six months or greater
- NYHA Class III
- Have had at least one (1) heart failure hospitalization within the last year OR have an elevated BNP level of at least 300 pg/ml or an NT-proBNP level of at least 1,500 pg/ml (The BNP/NT-proBNP may be corrected for patient’s body mass index (BMI))
- Receiving Class I recommended cardiac resynchronization therapy (CRT) for 30 days or more (This may be waived if contraindicated or patient refused treatment)
- Not expected to require another transseptal procedure within 6 months
- Taking maximally tolerated doses of guideline directed medical therapy (GDMT)
Contraindications
• LVEF >40%
• Tricuspid annular plane systolic excursion <12 or a right ventricular fraction area change ≤25%
• Mitral repair procedure performed within the last three (3) months
• Tamponade or large pericardial effusion
• Patients who have had a stroke, transient ischemic attack (TIA), pulmonary thromboembolism, or deep vein thrombosis (DVT) in the last 6 months
• Unresolved, non-organized or mobile intracardiac thrombus or central venous thrombus
• Patients who are more likely to benefit from LVAD or cardiac transplantation
• Known allergies to nickel, titanium, ePTFE, or other device materials
• Unable to tolerate procedural anticoagulation regimen and/or post procedural antiplatelet therapy
• Right atrial pressure (RAP) > pulmonary capillary wedge pressure (PCWP) or left atrial pressure (LAP) during the right heart catheterization (RHC) assessment
• Patent foramen ovale (PFO) or atrial septal defect (ASD) with more than trace shunting, or prior repair of PFO or ASD by means other than stitching
• Anatomical anomalies that preclude proper implantation of the device across the fossa ovalis, including:–fossa ovalis thickness >6 mm–fossa ovalis length <10 mm– inadequate vascular access, or inability to perform safe transseptal catheterization of the left atrium
• Active bacterial endocarditis or other active infections
• Clinical or hemodynamic instability
• Mean PCWP >35 mmHg not correctable by medical therapy
• Pulmonary artery systolic pressure (PASP) >70 mmHg associated with pulmonary vascular resistance (PVR) >4.0 Wood units, that cannot be reduced to a PVR ≤4 Wood units by acute vasodilator therapy
• Unable to lie flat and be safely sedated or put under general anesthesia and tolerate transseptal catheterization and ancillary catheterization/implant procedures required for implantation
MP-0005687 rev. 2.0