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)

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 Overview

• Status: Withdrawn
• Conditions: Heart Failure; Pulmonary Hypertension
• Intervention / Treatment: Device: Rivet Shunt

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • UVA Cardiology Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivet Shunt Therapy	Device: Rivet Shunt; The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Hemodynamics at 12 months - PCWP	Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline	12 Months
Change in Kansas City Cardiomyopathy Questionnaire	Change in KCCQ score between baseline and 12 months.	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	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	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	12 months

Collaborators and Investigators

• Sponsor: NXT Biomedical

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Failure; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: CIP-A-21-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes