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)

NXT Biomedical3 sites in 1 countryMay 10, 2022

ConditionsHeart Failure Pulmonary Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: NXT Biomedical
Locations: 3
Primary Endpoint: Rate of Technical Success of the Rivet Shunt Implantation Procedure
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 10, 2022

End Date

December 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NXT Biomedical

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Rate of Technical Success of the Rivet Shunt Implantation Procedure

Time Frame: 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.

Rate of Major Adverse Events

Time Frame: 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)