Rivet PVS Therapy in Group 2 PH-HFpEF
Heart Failure, Pulmonary Hypertension
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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:
- NYHA HF Class II with history > II, or Class III, or ambulatory Class IV
- ≥ 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
- Greater than moderate RV dysfunction as assessed by TTE and/or MRI
- RV FAC < 35%
- TAPSE < 14 mm via TTE
- 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:
- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
- If BMI < 30, Cardiac Index < 2.0 L/min/m2
- If BMI ≥ 30, Cardiac Index < 1.8 L/min/m2
- Requires continuous intravenous inotropic infusion
- Requires mechanical circulatory support
- Currently on the cardiac transplant waiting list
Chronic renal dysfunction defined as one or more of the following:
- Currently requiring dialysis; OR
- eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation
Chronic pulmonary disease defined as one or more of the following:
- Requires continuous home oxygen therapy
- Recent hospitalization for exacerbation within 12 months prior to screening
- FEV1 < 50% predicted
Sites / Locations
- Massachusetts General Hospital
- Mayo Clinic
- UVA Cardiology Research
Arms of the Study
Arm 1
Experimental
Rivet Shunt Therapy