Rivet PVS Therapy in Group 2 PH-HFpEF Canada

Trial details

Who runs it

NXT Biomedical

Trial code

NCT05332873

Record updated

2024. június 3.

Original description

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.Read full original descriptionShow less

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)

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; mPAP > 20 mmHg at rest; 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:; 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 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; 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; 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: 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.

ClinicalTrials.gov NCT05332873