Heart Failure Clinical Trial
Official title:
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)
Verified date | May 2024 |
Source | NXT Biomedical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | UVA Cardiology Research | Charlottesville | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
NXT Biomedical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Change in Hemodynamics at 12 months - PCWP | Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline | 12 Months | |
Secondary | Change in Kansas City Cardiomyopathy Questionnaire | Change in KCCQ score between baseline and 12 months. | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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