Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

Exclusion Criteria

• •Stroke or thromboembolic event in the past 6 months.
• •Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD \> 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment.
• •Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment.
• •More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment.
• •Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease.
• •BMI \> 40.
• •6-minute Walk Test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test.
• •Any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate \> 100 bpm, systolic blood pressure greater than 170 mmHg (average of 3 measurements at baseline).
• •Evidence of precapillary pulmonary hypertension defined as PVR \> 2 Wood units at rest, TPG \> 15 at rest or with exercise, resting RA \> 15 mmHg, or RA to PCWP ratio \> 0.7 at rest and with exercise.
• •Anatomic anomaly that precludes creation of interatrial shunt.