1. Safety-Percentage of Treatment patients experiencing major device-related adverse events [30-days after randomization]
   Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
2. Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) [Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months]
   Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method

1. 6MWT changes [Baseline to 12 months]
   6MWT changes
2. KCCQ changes [Baseline to 12 months]
   KCCQ changes
3. KCCQ changes [Baseline through study completion, maximum of five years]
   KCCQ changes
4. Time to all-cause death, LVAD/Transplant, or heart failure hospitalization [Baseline through study completion, maximum of five years]
   Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
5. Time to all-cause death or first heart failure hospitalization [Baseline through study completion, maximum of five years]
   Time to all-cause death or first heart failure hospitalization
6. Cumulative heart failure hospitalizations [Baseline through study completion, maximum of five years]
   Cumulative heart failure hospitalizations
7. Time to first heart failure hospitalization [Baseline through study completion, maximum of five years]
   Time to first heart failure hospitalization
8. Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ [Baseline through study completion, maximum of five years]
   Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ

• Heart Failure

Device: V-Wave Interatrial Shunt

The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.

Experimental: Treatment
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation

• Device: V-Wave Interatrial Shunt

Other: Control
Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.

• Other: Control

Experimental: Roll in
Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation

• Device: V-Wave Interatrial Shunt

Inclusion Criteria:

• ia:
• Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
• NYHA Class II, Class III, or ambulatory Class IV HF
• Receiving guideline directed medical and device therapy (GDMT) for heart failure
• For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
• For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
• Mai

Exclusion Criteria:

• Systolic blood pressure <90 or >160 mmHg
• Presence of Intracardiac thrombus
• Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU
• Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
• Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
• Moderate to severe aortic or mitral stenosis
• Stroke or TIA or DVT within the last 6 months
• eGFR <25 ml/min/1.73 m^2
• Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
• Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
• Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: Yes

Product Manufactured in and Exported from the U.S.: Not Provided