An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System

Aria CV, Inc12 sites in 1 country30 target enrollmentMarch 15, 2021

ConditionsPulmonary Arterial Hypertension Pulmonary Hypertension Right Heart Dysfunction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pulmonary Arterial Hypertension
Sponsor: Aria CV, Inc
Enrollment: 30
Locations: 12
Primary Endpoint: Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs).
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective study is a multi-center early feasibility study assessing the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary hypertension and right heart dysfunction.

Detailed Description

This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary hypertension (PH). The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient and to evaluate its performance in treating patients with PH and right heart dysfunction. The study will be conducted in a maximum of 20 centers in the United States and up to 30 patients will receive implants. Patients will be evaluated at each of the following time intervals: pre-operative, implant procedure, 7-day (or discharge if earlier), and 1-, 2-, 3-, 4-, 6-, 9-, 12-, 15-, 18-, 21-, and 24-months post index procedure. The Aria CV PH System will be assessed at each follow-up visit. The duration of the study is anticipated to last about 2 years for each patient.

Registry

clinicaltrials.gov

Start Date

March 15, 2021

End Date

October 1, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Aria CV, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or older.
•Mean pulmonary artery pressure (mPAP) \> 25mmHg.
•Right heart dysfunction as evidence by at least one of the following:
•Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm
•RV Fractional area change \< 35%
•RV systolic velocity \< 11.5 cm/s
•RV free wall strain \< 18%
•Lateral tricuspid annulus peak systolic velocity (S') \< 9cm/s
•Pulmonary compliance (C) \< 3.0 ml/mmHg
•Current assessment of WHO FC III or ambulatory IV

Exclusion Criteria

•Diagnosis of WHO Groups 4 or 5 PH.
•Recent clinical event(s) of any of the following:
•Myocardial infarction or stroke within 6 months prior to the index procedure;
•Sustained tachyarrhythmia (documented heart rate \>110/min) within 2 months prior to the index procedure;
•Uncontrolled, chronic atrial fibrillation.
•Pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that, in the opinion of the investigator, may interfere with Aria CV PH System placement or function.
•Any of the following medical history or comorbidities:
•a. History of endocarditis; b. History of unprovoked Pulmonary Embolism; c. Current renal insufficiency as demonstrated by an eGFR \< 30 mL/min/1.73 m2 or end stage renal disease requiring chronic dialysis; d. Current diagnosis of scleroderma associated with: i. Any history of GI bleeding or receiving iron infusions within 2 years prior to enrollment; ii. Significant skin involvement that could compromise daily activities or the ability to receive IV medications, or sclerodactyly that causes surface ulcerations, digital ulcerations, or ulcerating calcinosis lesions.
•e. History of receiving immunosuppressant therapy as follows: i. Excluded if receiving Mycophenolate mofetil within 30 days prior to enrollment, or Rituximab within 6 months prior to enrollment, or currently receiving Prednisone at a dose \> 12 mg per day at time of enrollment; ii. Excluded if any immunosuppressant other than Mycophenolate mofetil, Rituximab or Prednisone, per above.
•e. Current pulmonary veno-occlusive disease (PVOD); f. Current pulmonary capillary hemangiomatosis (PCH); g. History of clinically significant patent foramen ovale (PFO) or other inter-atrial or inter-ventricular shunt; h. History of gastric antral vascular ectasia (GAVE), gastrointestinal or intracranial bleeding which, in the opinion of the investigator, will predispose subject to major bleeding events following Aria CV device placement and warfarin anticoagulation regimen; i. Active infection requiring antibiotic therapy within two (2) weeks of procedure; j. Blood dyscrasias that may, in the opinion of investigator(s), expose subject to unacceptable procedural risks such as severe or worsening leukopenia, anemia, thrombocytopenia, untreated iron deficiency or history of bleeding diathesis or coagulopathy.

Outcomes

Primary Outcomes

Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs).

Time Frame: 30 days post-implant

The primary safety endpoint is the incidence of investigational device- or procedure-related serious adverse events through 30 days post-index procedure.

Secondary Outcomes

Changes in pulmonary artery pressures (PAPs)(6 months post-implant)
Changes in quality of life as measured by the Living with Pulmonary Hypertension (LPH) questionnaire score(6-months post-implant)
Changes in right heart function(6 months post-implant)
Changes in World Health Organization (WHO) Functional Class(6 months post-implant)
Changes in 6-Minute Walk Distance(6 months post-implant)
Changes in biomarker N-terminal pro hormone BNP (NT-pro-BNP)(6 months post-implant)
Changes in REVEAL Score(6 months post-implant)
Changes in quality of life as measured by the emPHasis-10 questionnaire score(6-months post-implant)
Changes in pulmonary vascular resistance (PVR)(6 months post-implant)
Changes in pulmonary arterial compliance(6 months post-implant)
Incidence of Device Implantation Success(7 days post-implant)
Changes in Modified Borg Dyspnea Score (MBS)(6 months post-implant)
Incidence of Serious Adverse Events(24 months post-implant)
Changes in pulmonary capillary wedge pressure (PCWP)(6 months post-implant)
Changes in cardiac output (CO) from baseline(6 months post-implant)