Ensayos clínicos

Select Inclusion Criteria:

- Age ≥ 18 years.

- Prior diagnosis of Group 2 PH due to HFpEF, with the following resting hemodynamic criteria confirmed in the past year by right heart catheterization.

a. mPAP ≥ 25 mmHg at rest or mPAP/CO slope > 3 mmHg/L/min during incremental exercise.

- Confirmation of the following hemodynamic criteria during supine exercise.

a. PCWP ≥ 25 mmHg, or PCWP/CO slope > 2 mmHg/L/min.

- Chronic symptomatic heart failure documented by the following:

1. NYHA HF Class II with history > II, or Class III or ambulatory Class IV.

2. ≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value > 400 pg/mL in normal sinus rhythm or > 750 pg/mL in atrial fibrillation in past 6
months.

- Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating HF physician according to current ACCF/AHA guidelines that is
expected to be maintained without change for 6 months (excluding diuretic dosage changes for HF optimization within 90 days of the Index Procedure).

- 6MWD ≥ 150 m.

Select Exclusion Criteria:

- Any therapeutic intracardiac intervention within the last 30 days.

- PH Group 1, 3, 4 or 5.

- Mean RAP >12 mmHg by RHC at rest on room air.

- Right ventricular dysfunction, defined as one or more of the following.

1. Greater than moderate RV dysfunction as assessed by TTE and/or MRI.

2. RV FAC < 35%.

3. TAPSE < 14 mm via TTE.

4. RV size severely enlarged compared to LV size as estimated by TTE and/or MRI.

- Severe tricuspid valve regurgitation.

- Peak systolic pulmonary arterial pressure > 80 mmHg by RHC at rest while awake.

- Mean pulmonary arterial pressure > 50 mmHg by RHC at rest while awake.

- PVR > 6 Wood units at rest while awake on room air or exercise PVR > 2 Wood Units.

- Left ventricular ejection fraction < 50%.

- Severe heart failure, defined as one or more of the following:.

1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.

2. If BMI < 30, Cardiac Index < 2.0 L/min/m^2.

3. If BMI ≥ 30, Cardiac Index < 1.8 L/min/m^2.

4. Requires continuous intravenous inotropic infusion.

5. Requires mechanical circulatory support.

6. Currently on the cardiac transplant waiting list.

- Chronic renal dysfunction defined as one or more of the following:

1. Currently requiring dialysis; OR

2. eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation.

- Chronic pulmonary disease defined as one or more of the following:

1. Requires continuous home oxygen therapy;

2. Recent hospitalization for exacerbation within 12 months prior to screening;

3. FEV1 < 50% predicted.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.