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Rivet PVS Therapy in Group 2 PH-HFpEF | Clinical Trials | Clareo Health

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Rivet PVS Therapy in Group 2 PH-HFpEF

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)

NCT05205265•NXT Biomedical

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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
+17 more criteria

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

UVA Cardiology Research

Charlottesville, Virginia, United States

Key Dates

Start Date

May 10, 2022

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

June 3, 2024

Conditions

Heart FailurePulmonary Hypertension

Interventions

Rivet Shunt

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rivet PVS Therapy in Group 2 PH-HFpEF

Inclusion Criteria

Exclusion Criteria

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