Rivet PVS Therapy in Group 2 PH-HFpEF

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of the Rivet Pulmonary-to-Venous Shunt (PVS) Therapy in Patients With Group 2 Pulmonary Hypertension (PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Conditions
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Heart Failure, Pulmonary Hypertension

Intervention / Treatment
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* Device: Rivet Shunt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivet Shunt Therapy<br> | Device: Rivet Shunt<br>* The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Adverse Events | Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at implantation procedure (Day 0) and up to 1-month post-procedure (Day 30) | 1 month | 
| Rate of Technical Success of the Rivet Shunt Implantation Procedure | Study device is implanted as intended and confirmation of a patent pulmonary-to-venous shunt between the RPA and SVC by qualitative assessment via angiography and/or echocardiography at implantation procedure. | At time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events through 12 months | Composite of MACCRE and re-intervention for study device related complications (as described above), progression of PH and/or HF disease, and all-cause mortality to 12 months post-procedure | 12 months | 
| Change in Hemodynamics at 12 months - PCWP | Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline | 12 Months | 
| Change in Kansas City Cardiomyopathy Questionnaire | Change in KCCQ score between baseline and 12 months. | 12 months | 
| Change in RV Chamber Size at 12 months - Diameter | Change in RV Chamber Size (Diameter) assessed by a core lab between baseline and 12 months | 12 months | 
| Change in Hemodynamics at 12 months - mPAP/CO Slope | Change in exercise mPAP/CO Slope (mean pulmonary artery pressure/cardiac output slope) from baseline | 12 months | 
| Change in RV function at 12 months - RV Fractional Area Change (FAC) | Change in RV FAC assessed by a core lab between baseline and 12 months | 12 months |