Heart Failure, Pulmonary Hypertension
Conditions
Brief summary
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.
Interventions
DEVICERivet Shunt
The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach
Sponsors
NXT Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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: 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/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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events | 1 month | 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) |
| Rate of Technical Success of the Rivet Shunt Implantation Procedure | At time of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events through 12 months | 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 |
| Change in Hemodynamics at 12 months - PCWP | 12 Months | Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline |
| Change in Kansas City Cardiomyopathy Questionnaire | 12 months | Change in KCCQ score between baseline and 12 months. |
| Change in RV function at 12 months - RV Fractional Area Change (FAC) | 12 months | Change in RV FAC assessed by a core lab between baseline and 12 months |
| Change in Hemodynamics at 12 months - mPAP/CO Slope | 12 months | Change in exercise mPAP/CO Slope (mean pulmonary artery pressure/cardiac output slope) from baseline |
| Change in RV Chamber Size at 12 months - Diameter | 12 months | Change in RV Chamber Size (Diameter) assessed by a core lab between baseline and 12 months |
Countries
United States
Outcome results
None listed