Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
10. Significant hepatic impairment defined as 3× upper limit of normal of transaminases,
total bilirubin, or alkaline phosphatase
11. Performance of the 6 minute walk test with a distance <50m OR >600m 12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin
(analogue); or has a documented coagulopathy
13. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be
adequately medicated
14. Known hypersensitivity to Nickel and/or Tantalum 15. In the judgment of the investigator, life expectancy <12 months for noncardiovascular
reasons
16. In the opinion of the investigator, the subject is not an appropriate candidate for
the study
17. Anatomy (including implantable devices) that is not compatible with the Edwards
Transcatheter Atrial Shunt System
18. Active endocarditis or infection within 3 months of scheduled implant procedure 19. Currently participating (e.g., undergoing trial specific exams/treatment/procedures)
in an investigational drug or device study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational trials.
20. Patient is a current intravenous recreational drug user 21. Positive serum pregnancy test in female subjects of child-bearing potential or nursing
mothers or planning on becoming pregnant during the duration of the trial
22. Patient is under guardianship 23. Known pre-existing shunting, determined to be clinically significant by the
investigator
24. (Not applicable to Cohort B) Right ventricular dysfunction, defined by the site
cardiologist as:
- More than mild RV dysfunction as estimated by TTE; OR
- TAPSE <1.4 cm; OR
- RV size ≥ LV size as estimated by TTE; OR
- Echocardiographic or clinical evidence of congestive hepatopathy
- Evidence of pulmonary vascular disease with PVR >3.0 Wood units
Exclusion Criteria for Cohort B, Heart Failure with Pulmonary Vascular Disease only:
- Propensity for increased Right ventricular dysfunction, defined by the site cardiologist as: