NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)

Inclusion Criteria:

1. Age≥18 years old.
2. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
3. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion)at screening visit; or signs (Any rales post cough, Chest x-ray demonstratingpulmonary congestion,) within past 12 months;
4. One hospital admission for which HF was a major component of the hospitalizationwithin the 12 months prior to study entry (transient heart failure in the contextof myocardial infarction does not qualify).
5. Sustained and stable GDMT (guideline-directed medical therapy) for heart failureaccording to the 2017 ACC/AHA/HFSA guidelines management as well as potentialcomplications of heart failure management, heart failure symptoms remain uncontrolled.
6. LV ejection fraction (EF) ≥15% measured by echocardiography in the last 6 months.
7. Invasive hemodynamic measurements showed mLAP or end-expiratory resting PCWP≥15mmHg,and mLAP or PCWP-RAP ≥5mmHg.
8. Subject has been informed of the nature of the study, agrees to its provisions, andhas provided written informed consent, as approved by the IRB.

Exclusion Criteria:

1. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
2. Bacterial endocarditis.
3. 6-minute walk test distance <100m or > 450m.
4. History of atrial septum implantation (e.g. atrial septum occlusion, patent foramenovale occlusion) or inferior vena cava filter.
5. History of myocardial infarction (MI), percutaneous coronary intervention (PCI), orcoronary artery bypass grafting (CABG) within the past 3 months; Untreated severecoronary artery stenosis which requires revascularization.
6. History of cardiac resynchronization therapy (CRT/CRT-D) or implantablecardioverter-defibrillator (ICD) implantation within the past 6 months.
7. Right heart failure
8. Pulmonary arterial hypertension (TTE or cardiac catheterization shows pulmonary arterysystolic pressure>70mmHg)
9. Life expectancy less than 12 months.
10. In the opinion of the investigator, the subject is not an appropriate candidate forthe study.