Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension

NCT05001711 | Completed DMC

• 1 other identifier: ARIACV202101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  Incidence of investigational device-related serious adverse events (SAEs) through 30 days post-index procedure, based on Clinical Events Committee assessment.

  30 Days

Secondary Outcomes (1)

• Secondary Safety Endpoint

  30 Days

Study Arms (2)

WHO Group 2

EXPERIMENTAL

Device: Aria CV Acute PH System

WHO Group 3

EXPERIMENTAL

Device: Aria CV Acute PH System

Interventions

Aria CV Acute PH System DEVICE

The Aria CV Acute PH System is indicated for evaluation of hemodynamic responses (e.g. pulmonary arterial compliance, cardiac output, and effective arterial elastance) to an intravascular Balloon catheter temporarily placed in the pulmonary artery in symptomatic adult patients with WHO Group 2 or WHO Group 3 pulmonary hypertension and right ventricular dysfunction.

WHO Group 2; WHO Group 3

Eligibility Criteria

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

You may qualify if:

• years or older
• Symptomatic WHO Functional Class (FC) III
• Based on preexisting echocardiography within the past 6 months, evidence of right heart dysfunction: RV ejection fraction (RVEF) \< 45% by visual estimate, and at least one of the following:
• Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm
• RV Fractional area change \<35%
• RVs' velocity \< 10 cm/s
• RV free wall strain \<18%
• RVEF \< 35% by visual estimate
• MPA diameter \> 32mm and length \>70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months.
• Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) \> 30 mmHg
• Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting RHC: mPAP \> 30 mmHg
• Patient is willing and able to provide informed consent.
• Previous diagnosis of left heart dysfunction.
• Intra-procedural confirmation of WHO Group 2 diagnosis based on resting RHC:
• PAWP: \>15 and ≤30 mmHg, and

You may not qualify if:

• Anatomy not suitable for RHC
• Anatomy not suitable for placement of Aria CV Acute Device:
• Contraindication to 16 Fr femoral vein access
• Body habitus that would preclude safe placement of any components of Aria CV Acute Device
• Any previous tricuspid valvular surgery, percutaneous valve repair, or presence of prosthetic cardiac device such as pacemaker or defibrillator leads, or vena cava filter that in the opinion of the investigator may interfere with investigational device placement or performance
• Uncontrolled atrial fibrillation
• Sustained tachyarrhythmia (heart rate \>110/min) at time of index procedure
• Right heart valve regurgitation:
• Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation
• Severe (Grade 4) tricuspid valve regurgitation
• Patient with any of the following medical history or comorbidities:
• History of unprovoked Pulmonary Embolism or CTEPH
• Currently on dialysis
• Current or recent (\<6 months prior to planned index procedure) endocarditis
• Clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt

Sponsors & Collaborators

• Aria CV, Inc: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Irene M Lang, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 12, 2021
• Study Start: July 12, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 6, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

AU (1)