Commercial decision

This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.

Select Inclusion Criteria:

• Age ≥ 18 years

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

  1. mPAP > 20 mmHg at rest
  2. mPAP/CO slope > 3 mmHg/L/min with exercise

• Confirmation of the following hemodynamic criteria during supine exercise: 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 cardiologist according to current ACCF/AHA guidelines that is expected to be maintained without change for 1 month (excluding diuretic dosage changes for HF optimization within 30 days of the Index Procedure)

• 6MWD ≥ 100 m

Select Exclusion Criteria:

• Any therapeutic intracardiac intervention within the last 30 days

• PH Group 1, 3, 4 or 5

• Mean RAP >16 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

• 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/m2
  3. If BMI ≥ 30, Cardiac Index < 1.8 L/min/m2
  4. Requires continuous intravenous inotropic infusion
  5. Requires mechanical circulatory support
  6. Currently on the cardiac transplant waiting list

• Chronic renal dysfunction defined as: 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