Nitric Oxide, GeNO Nitrosyl Delivery System

Investigational product will be administered by qualified study staff in accordance with the procedures described in the protocol and in accordance with the detailed set of instructions supplied with the initial shipment of investigational product.

Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM.

In order to reliably measure trace levels of NO2 in the presence of a large excess of NO, it is essential to use a technique with extremely high accuracy in situations of low levels of NO2. The GeNO nitrosyl delivery system delivers a fixed concentration of 80ppm NO with low levels of NO2 which current technology cannot measure with accuracy at levels below 3ppm.

The investigational product is the GeNO nitrosyl delivery system which consists of a drug/device combination product with all the components necessary to deliver the investigational drug; the nitric oxide gas. The investigational drug, nitric oxide, is generated at the time of use when the NO2 input gas flows through the cartridge, the antioxidant reduces the NO2 to NO.

The input gas is supplied as either nitric oxide in air or nitric oxide in oxygen. The Investigator will determine whether air or oxygen is used as the balance gas, on the basis of the participant's clinical needs for supplemental oxygen.

Inclusion criteria

• An Institutional Review board (IRB) approved informed consent is signed, dated and timed prior to any study-related activities.
• Male or female > 18 years of age.
• Being evaluated for OHT or LVAD implantation and scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity.
• Have a confirmed diagnosis of heart failure, (NYHA Class III or IV)
• Participant has the ability to understand the requirements of the study and a willingness to comply with all study procedures.
• Females of childbearing potential with a negative urine pregnancy test, or a documented surgical sterilization, or is post-menopausal prior to administration of investigational product. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator's responsibility to determine whether the Participant has adequate birth control for study participation.
• Confirmed pulmonary arterial hypertension at time of RHC:

• PAPm > 25mmHg at rest and PVR > 3 Wood units

Exclusion criteria

• Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
• Have had an atrial septostomy.
• Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
• Have any serious or life-threatening disease other than conditions (e.g. malignancy requiring aggressive chemotherapy, etc.).
• Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial, or any condition, which in the investigator's opinion would constitute an unacceptable risk to the participant's safety.
• Participant is pregnant or lactating