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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

⁃ Pulmonary vascular resistance (PVR) \> 3 Woods Units (WU)

⁃ The subject remains symptomatic despite being on a stable drug regimen of PH specific medication(s) appropriate for their PH classification for at least 90 days prior to planned index procedure.

• 10\. Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) 11. PCWP \> 15 mmHg 12. PVR \> 3 WU

• 10\. Previous diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis.

• 11\. PCWP ≤ 15mmHg 12. PVR \>4 WU

Locations
United States
California
University of California - San Diego
WITHDRAWN
La Jolla
University of California-Los Angeles
RECRUITING
Los Angeles
Indiana
St. Vincent Health
RECRUITING
Indianapolis
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
New York
Cornell University
RECRUITING
New York
University of Rochester
RECRUITING
New York
Ohio
The Christ Hospital
WITHDRAWN
Cincinnati
Ohio Health
RECRUITING
Columbus
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Wisconsin
Aurora St Luke's Medical Center
WITHDRAWN
Milwaukee
Contact Information
Primary
Caytie Longhenry
clonghenry@ariacv.com
651-200-4891
Backup
VP of Clinical
Time Frame
Start Date: 2021-03-15
Estimated Completion Date: 2026-10
Participants
Target number of participants: 30
Treatments
Experimental: Aria CV Pulmonary Hypertension System
Treatment with the Aria CV Pulmonary Hypertension System
Related Therapeutic Areas
Sponsors
Leads: Aria CV, Inc

This content was sourced from clinicaltrials.gov