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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
UVA Cardiology Research
Charlottesville, Virginia, United States
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)
Time frame: 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.
Time frame: At time of procedure
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
Time frame: 12 months
Change in Hemodynamics at 12 months - PCWP
Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline
Time frame: 12 Months
Change in Kansas City Cardiomyopathy Questionnaire
Change in KCCQ score between baseline and 12 months.
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 12 months