Rivet PVS Therapy in Group 2 PH-HFpEF

Heart Failure Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05205265
• Other study ID #: CIP-A-21-0001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: NXT Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• Rivet Shunt
The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	UVA Cardiology Research	Charlottesville	Virginia
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
NXT Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change in Hemodynamics at 12 months - PCWP	Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline	12 Months
Secondary	Change in Kansas City Cardiomyopathy Questionnaire	Change in KCCQ score between baseline and 12 months.	12 months
Secondary	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
Secondary	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
Secondary	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