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Rivet PVS Therapy in Group 2 PH-HFpEF

Primary Purpose

Heart Failure, Pulmonary Hypertension

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rivet Shunt
Sponsored by
NXT Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Mayo Clinic
  • UVA Cardiology Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rivet Shunt Therapy

Arm Description

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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
Change in Hemodynamics at 12 months - PCWP
Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline
Change in Kansas City Cardiomyopathy Questionnaire
Change in KCCQ score between baseline and 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
Change in Hemodynamics at 12 months - mPAP/CO Slope
Change in exercise mPAP/CO Slope (mean pulmonary artery pressure/cardiac output slope) from baseline
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

Full Information

First Posted
November 17, 2021
Last Updated
April 10, 2023
Sponsor
NXT Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT05205265
Brief Title
Rivet PVS Therapy in Group 2 PH-HFpEF
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NXT Biomedical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivet Shunt Therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Rivet Shunt
Intervention Description
The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach
Primary Outcome Measure Information:
Title
Rate of Major Adverse Events
Description
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
Title
Rate of Technical Success of the Rivet Shunt Implantation Procedure
Description
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
Secondary Outcome Measure Information:
Title
Adverse Events through 12 months
Description
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
Title
Change in Hemodynamics at 12 months - PCWP
Description
Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline
Time Frame
12 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire
Description
Change in KCCQ score between baseline and 12 months.
Time Frame
12 months
Title
Change in RV Chamber Size at 12 months - Diameter
Description
Change in RV Chamber Size (Diameter) assessed by a core lab between baseline and 12 months
Time Frame
12 months
Title
Change in Hemodynamics at 12 months - mPAP/CO Slope
Description
Change in exercise mPAP/CO Slope (mean pulmonary artery pressure/cardiac output slope) from baseline
Time Frame
12 months
Title
Change in RV function at 12 months - RV Fractional Area Change (FAC)
Description
Change in RV FAC assessed by a core lab between baseline and 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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 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 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: ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF If BMI < 30, Cardiac Index < 2.0 L/min/m2 If BMI ≥ 30, Cardiac Index < 1.8 L/min/m2 Requires continuous intravenous inotropic infusion Requires mechanical circulatory support Currently on the cardiac transplant waiting list Chronic renal dysfunction defined as one or more of the following: Currently requiring dialysis; OR eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation Chronic pulmonary disease defined as one or more of the following: Requires continuous home oxygen therapy Recent hospitalization for exacerbation within 12 months prior to screening FEV1 < 50% predicted
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
UVA Cardiology Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Rivet PVS Therapy in Group 2 PH-HFpEF

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