Heart Failure (HF) Interatrial Shunt Study 1

Exclusion Criteria

• •1. Age \<18 or \>85 years old
• •2. BMI \<18 or \>40 kg/m2
• •3. systolic blood pressure \<90 or \>160 mmHg
• •4. Has baseline 2-D echocardiographic evidence of, or history of, unresolved or non- organized intracardiac thrombus
• •5. Has Pulmonary Hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram.
• •6. Significant RV dysfunction defined echocardiographically as TAPSE \<12mm or RVFAC ≤30%.
• •7. Left Ventricular End-Diastolic Diameter (LVEDD) \> 8cm
• •8. Has an Atrial Septal Defect or Patent Foramen Ovale with more than trace shunting on color Doppler or intravenous bubble study or prior surgical or interventional correction of congenital heart disease involving atrial septum including placement of a PFO or ASD closure device
• •9. Had a Stroke, Transient Ischemic Attack, Systemic or Pulmonary Thromboembolism, or Deep Vein Thrombosis (DVT) within the last 6 months, or any prior stroke with permanent neurologic defect.
• •10. Has untreated severe stenotic or regurgitant valve lesions, or coronary stenoses which are anticipated to require surgical or percutaneous intervention within 6 months, active valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion, constrictive pericarditis, infiltrative cardiomyopathy (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as cause of HF.
• •11. Transseptal procedure is anticipated within 6 months after the V-Wave Shunt implant.
• •12. Bradycardia with heart rate \<45 bpm (unless treated with a permanent pacemaker) or uncontrolled tachyarrhythmias.
• •13. Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D).
• •14. Intolerant to both ACEI and ARB and beta-blocker medical therapy for patients classified as HFrEF (EF ≤40%).
• •15. Had an acute MI, Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), Rhythm Management system revision, lead extraction, or cardiac or other major surgery within 30 days.
• •17. Has a life expectancy \<1 year due to non-cardiovascular illness.
• •18. Has contraindications to all of the study-related anticoagulation/antiplatelet regimens
• •19. Has an Estimated Glomerular Filtration Rate \<30 ml/min/1.73 m2 by the MDRD method or is receiving dialysis.
• •20. Hepatic impairment with at least one liver Function Test
• •21. Severe chronic Pulmonary Disease
• •22. Active infection requiring systemic antibiotics.
• •1. Unable to undergo both TEE and ICE.
• •2. Anatomical anomaly on TEE or ICE
• •3. Has inadequate vascular access for implantation of shunt.
• •4. Hemodynamic anomaly or instability at time of FEC