Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System

Part of paid clinical trials in La Jolla, California.

Sponsor
Aria CV, Inc
Study ID
NCT04555161
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Right Heart Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aria CV Pulmonary Hypertension System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 15, 2021
Status verified
Sep 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aria CV Pulmonary Hypertension System
    Treatment with the Aria CV Pulmonary Hypertension System

Primary Outcome Measure

Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs). [ Time Frame: 30 days post-implant ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of California - San DiegoLa JollaCalifornia92093-
University of California-Los AngelesLos AngelesCalifornia90095
Richard Channick, MD (PRINCIPAL_INVESTIGATOR)
Rajan Saggar, MD (SUB_INVESTIGATOR)
Alexander Sherman, MD (SUB_INVESTIGATOR)
Peyman Benharash, MD (SUB_INVESTIGATOR)
Ali Nsair, MD (SUB_INVESTIGATOR)
St. Vincent HealthIndianapolisIndiana46260
Allyn (Ryn) Harker
[email protected]
Ashwin Ravichandran, MD (PRINCIPAL_INVESTIGATOR)
Scott Hittinger, MD (SUB_INVESTIGATOR)
Amit Patel, MD (SUB_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Olivia Vayer
[email protected]
Eileen Harder, MD (PRINCIPAL_INVESTIGATOR)
Aaron Waxman, MD (SUB_INVESTIGATOR)
Edgar Ross, MD (SUB_INVESTIGATOR)
Jane Leopold, MD (SUB_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55435
Gretchen Peichel, RN
[email protected]
Thenappan Thenappan, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Louise Durst
[email protected]
Robert Frantz (SUB_INVESTIGATOR)
Adrian da Silva de Abreu (PRINCIPAL_INVESTIGATOR)
Cornell UniversityNew YorkNew York10065
Joseph Lohmann
[email protected]
Evelyn Horn, MD (PRINCIPAL_INVESTIGATOR)
Harsimran Singh, MD (SUB_INVESTIGATOR)
Maria Karas, MD (SUB_INVESTIGATOR)
Berhane Worku, MD (SUB_INVESTIGATOR)
George Thomas, MD (SUB_INVESTIGATOR)
Yoshifumi Naka, MD (SUB_INVESTIGATOR)
University of RochesterNew YorkNew York14627
Andrew Mintz
[email protected]
Jim White, MD (PRINCIPAL_INVESTIGATOR)
Dan Lachant, DO (SUB_INVESTIGATOR)
Fred Ling, MD (SUB_INVESTIGATOR)
Kazuhiro Hisamoto, MD (SUB_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219-
Ohio HealthColumbusOhio43214
Sanchita Krishna
[email protected]
Lindsay Castle, MD (PRINCIPAL_INVESTIGATOR)
Steven Yakubov, MD (SUB_INVESTIGATOR)
Anupam Basuray, MD (SUB_INVESTIGATOR)
Daniel Gorbett, MD (SUB_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Shaquanda Goodwine
[email protected]
Michelle Esposito, MD (PRINCIPAL_INVESTIGATOR)
Aurora St Luke's Medical CenterMilwaukeeWisconsin53215-

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University of California - San Diego· La Jolla, CAUniversity of California-Los Angeles· Los Angeles, CASt. Vincent Health· Indianapolis, INBrigham and Women's Hospital· Boston, MAUniversity of Minnesota· Minneapolis, MNMayo Clinic· Rochester, MN

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