Rivet PVS Therapy in Group 2 PH-HFpEF

NCT ID: NCT05205265

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2023-12-31

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.

Conditions

Heart Failure; Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivet Shunt Therapy

Group Type: EXPERIMENTAL

Rivet Shunt

Intervention Type: DEVICE

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

Interventions

Rivet Shunt

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

Intervention Type: DEVICE

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:

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NXT Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

UVA Cardiology Research

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

CIP-A-21-0001

Identifier Type: -

Identifier Source: org_study_id