NCT04555161

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Mar 2021Oct 2026

First Submitted

Initial submission to the registry

August 31, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

4.6 years

First QC Date

August 31, 2020

Last Update Submit

September 24, 2025

Conditions

Pulmonary Arterial HypertensionPulmonary HypertensionRight Heart Dysfunction

Keywords

Pulmonary DiseasePulmonary ArteryPulmonary HypertensionLung DiseaseRight Heart Dysfunction

Outcome Measures

Primary Outcomes (1)

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

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

    30 days post-implant

Secondary Outcomes (15)

  • Incidence of Device Implantation Success

    7 days 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 Modified Borg Dyspnea Score (MBS)

    6 months post-implant

  • Changes in biomarker N-terminal pro hormone BNP (NT-pro-BNP)

    6 months post-implant

  • +10 more secondary outcomes

Study Arms (1)

Aria CV Pulmonary Hypertension System

EXPERIMENTAL

Treatment with the Aria CV Pulmonary Hypertension System

Device: Aria CV Pulmonary Hypertension System

Interventions

Aria CV Pulmonary Hypertension SystemDEVICE

The Aria CV PH System is indicated for the treatment of adult patients diagnosed with Pulmonary Hypertension in World Health Organization (WHO) Groups I, II, and III who remain symptomatic despite treatment with optimal medical therapy.

Also known as: Aria CV PH System
Aria CV Pulmonary Hypertension System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT).
  • Subject is deemed appropriate for Aria CV device by the Subject Care Team at the investigation site and approved by the Eligibility Review Committee (ERC).
  • The subject has agreed to participate in the study by signing the study specific informed consent form.
  • The subject agrees to abide by device related travel restrictions.
  • Pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg
  • +5 more criteria

You may not qualify if:

  • 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.
  • Anatomy is not suitable for placement of Aria CV device.
  • Right heart valve regurgitation as follows:
  • Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation;
  • Severe (Grade 4) tricuspid valve regurgitation.
  • Hypersensitivity or contraindication to:
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of California - San Diego

La Jolla, California, 92093, United States

WITHDRAWN

University of California-Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

St. Vincent Health

Indianapolis, Indiana, 46260, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55435, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Cornell University

New York, New York, 10065, United States

RECRUITING

University of Rochester

New York, New York, 14627, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

WITHDRAWN

Ohio Health

Columbus, Ohio, 43214, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

WITHDRAWN

Related Publications (1)

  • Vollmers K, Scandurra J, Woolley JR, Giridharan GA, Rothman AMK, Pritzker M, Weir EK, Gerges C, Lang I. Development of a Novel, Pulmonary Endovascular Device to Treat Patients With Pulmonary Hypertension. Pulm Circ. 2025 Jul 29;15(3):e70131. doi: 10.1002/pul2.70131. eCollection 2025 Jul.

    PMID: 40741160DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, PulmonaryLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Ashwin Ravichandran, M.D.

    Ascension Health

    PRINCIPAL INVESTIGATOR

  • Jim White, M.D., Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caytie Longhenry

CONTACT

651-200-4891clonghenry@ariacv.com

VP of Clinical

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm, non-randomized early feasibility study to evaluate the safety and feasibility of the Aria CV PH System in patients with pulmonary hypertension and right heart dysfunction.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 18, 2020

Study Start

March 15, 2021

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(12)