Rivet PVS Therapy in Group 2 PH-HFpEF

NCT05205265 | Withdrawn DMC FDA Device

• 1 other identifier: CIP-A-21-0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Adverse Events through 12 months

  12 months

• Change in Hemodynamics at 12 months - PCWP

  12 Months

• Change in Kansas City Cardiomyopathy Questionnaire

  12 months

• Change in RV Chamber Size at 12 months - Diameter

  12 months

• Change in Hemodynamics at 12 months - mPAP/CO Slope

  12 months

Study Arms (1)

Rivet Shunt Therapy

EXPERIMENTAL

Device: Rivet Shunt

Interventions

Rivet Shunt DEVICE

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

Rivet Shunt Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• MWD ≥ 150 m

You may not qualify if:

• 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

Sponsors & Collaborators

• NXT Biomedical: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UVA Cardiology Research

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: January 25, 2022
• Study Start: May 10, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)