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Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH)

Primary Purpose

Pulmonary Arterial Hypertension, Pulmonary Hypertension, Right Heart Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aria CV Pulmonary Hypertension System
Sponsored by
Aria CV, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Disease, Pulmonary Artery, Pulmonary Hypertension, Lung Disease, Right Heart Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years or older.
  2. Diagnosis of WHO Group 1 PH (Pulmonary Arterial Hypertension, PAH) evidenced by all the following parameters measured at rest:

    1. Mean pulmonary artery pressure (mPAP) ≥25 mmHg;
    2. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg;
    3. Pulmonary vascular resistance (PVR) >3 Wood units.
  3. Patient remains symptomatic despite being on a stable drug regimen of at least two PH specific medications for at least 90 days prior to planned index procedure.
  4. Patient with a current assessment of WHO Functional Class (FC) III or ambulatory IV.
  5. 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).
  6. Patient is deemed appropriate for Aria CV device by the Patient Care Team at the investigation site and approved by the Central Screening Committee (CSC).
  7. Patient understands the study requirements, is willing and able to provide appropriate informed consent and is committed and able to attend all required follow-up visits and undergo all required tests at the clinic.

Exclusion Criteria:

  1. Diagnosis of WHO PH Groups 2, 3, 4 or 5.
  2. Patient with recent clinical events of any of the following:

    1. Myocardial infarction or stroke within 6 months prior to the index procedure;
    2. Sustained tachyarrhythmia (documented heart rate >110/min) within 2 months prior to the index procedure.
  3. Any pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that may interfere with Aria CV device placement or function (e.g. pulmonary or tricuspid valve repair or replacement, pacemaker, defibrillator, inferior vena cava filters, neurostimulators, drug infusion devices, etc.).
  4. Patient with any of the following medical history or comorbidities:

    1. History of endocarditis;
    2. Current renal insufficiency as demonstrated by an eGFR <30 mL/min/1.73 m^2 or end stage renal disease requiring chronic dialysis;
    3. 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.

    d. 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 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. Current active systemic infection requiring antibiotic therapy;

    j. Blood dyscrasias that may, in the opinion of investigator(s), expose patient to unacceptable procedural risks such as severe or worsening leukopenia, anemia, thrombocytopenia, untreated iron deficiency or history of bleeding diathesis or coagulopathy.

  5. Anatomy not suitable for placement of Aria CV device, including

    1. No suitable subcutaneous implantation location for the reservoir;
    2. Contraindication to 22 Fr venous access via a subclavian vein;
    3. Body habitus that precludes safe placement of any components of the Aria CV device.
  6. Right heart valve regurgitation:

    1. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation;
    2. Severe (Grade 4) tricuspid valve regurgitation.
  7. Hypersensitivity or contraindication to

    1. Required medications (e.g. contrast agents, warfarin, heparin) which cannot be adequately managed;
    2. Materials in device including polyurethane, silicone, nickel, and titanium.
  8. Patient ineligible for or refuses blood transfusion.
  9. Pregnant or lactating female or planning a pregnancy during participation in the study.
  10. Patient with life expectancy of less than two years.
  11. Currently participating in or planning to participate in other investigational drug or device trials that may interfere with the outcome of this study

Sites / Locations

  • University of California - San Diego
  • University of California-Los Angeles
  • St. Vincent HealthRecruiting
  • Brigham and Women's Hospital
  • Beaumont HospitalRecruiting
  • University of Minnesota
  • Mayo Clinic
  • Cornell UniversityRecruiting
  • University of Rochester
  • The Christ HospitalRecruiting
  • The Ohio State University
  • Ohio HealthRecruiting
  • Medical University of South Carolina
  • Aurora St Luke's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aria CV Pulmonary Hypertension System

Arm Description

Treatment with the Aria CV Pulmonary Hypertension System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of Device Implantation Success
Incidence of successful implantation of the Aria CV device defined as follows: Absence of investigational device or procedure-related patient death within 7 days post index procedure based on Data Safety Monitoring Board (DSMB) adjudication; Correct positioning of the Aria CV device implantable components at the targeted locations upon completion of index procedure based on imaging; and Aria CV balloon inflates and deflates responding to cyclic pressure changes in the pulmonary artery at time of index procedure, based on imaging.
Changes in World Health Organization (WHO) Functional Class
Changes in WHO Functional Class from baseline to 6-month.
Changes in 6-Minute Walk Distance
Changes in the 6-minute walk distance from baseline to 6-month.
Changes in Modified Borg Dyspnea Score (MBS)
Changes in MBS from baseline to 6-months. MBS is a measure of breathlessness during exercise that ranges from 0 to 10, where 0 is no breathlessness and 10 is maximal breathlessness.
Changes in biomarker N-terminal pro hormone BNP (NT-pro-BNP)
Change in N-terminal pro hormone BNP (NT-pro-BNP) from baseline to 6-months.
Changes in REVEAL Score
Changes in REVEAL Score 2.0 from baseline to 6-months. The REVEAL 2.0 is a risk calculator for PAH patients that ranges from 0 (lowest risk) to 22 (highest risk).
Changes in quality of life as measured by the Living with Pulmonary Hypertension (LPH) questionnaire score
Changes in quality of life from baseline to 6-months as measured by the LPH total score. The Living with Pulmonary Hypertension (LPH) questionnaire has 21 questions each scored on a 6-point scale ranging from 0 (no) to 5 (very much). The LPH total score, calculated by summing scores for the 21 individual questions, ranges from 0 (best) to 105 (worst).
Changes in quality of life as measured by the emPHasis-10 questionnaire score
Changes in quality of life from baseline to 6-months as measured by the emPHasis-10 questionnaire score which assesses breathlessness, fatigue, confidence and control. The total score ranges from 0 to 50 with higher scores indicating poorer quality of life.
Incidence of Serious Adverse Events
Safety will be evaluated by assessing the incidence of device and/or procedure related SAEs from device implant through last follow up.
Changes in pulmonary vascular resistance (PVR)
Changes in PVR (Woods unit) as measured by right heart catheterization from baseline to 6 months.
Changes in pulmonary artery pressures (PAPs)
Changes in PAPs (mmHg) as measured by right heart catheterization from baseline to 6 months.
Changes in pulmonary capillary wedge pressure (PCWP)
Changes in PCWP (mmHg) as measured by right heart catheterization from baseline to 6 months.
Changes in pulmonary arterial compliance
Changes in pulmonary arterial compliance (L/mmHg) as measured by right heart catheterization from baseline to 6 months.
Changes in cardiac output (CO) from baseline
Changes in cardiac output (L/Min) as measured by right heart catheterization from baseline to 6 months.
Changes in right heart function
Changes in right heart function as measured by echocardiographic imaging.

Full Information

First Posted
August 31, 2020
Last Updated
September 21, 2023
Sponsor
Aria CV, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04555161
Brief Title
Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
Acronym
ASPIRE PH
Official Title
An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aria CV, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Pulmonary Hypertension, Right Heart Dysfunction
Keywords
Pulmonary Disease, Pulmonary Artery, Pulmonary Hypertension, Lung Disease, Right Heart Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aria CV Pulmonary Hypertension System
Arm Type
Experimental
Arm Description
Treatment with the Aria CV Pulmonary Hypertension System
Intervention Type
Device
Intervention Name(s)
Aria CV Pulmonary Hypertension System
Other Intervention Name(s)
Aria CV PH System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs).
Description
The primary safety endpoint is the incidence of investigational device- or procedure-related serious adverse events through 30 days post-index procedure.
Time Frame
30 days post-implant
Secondary Outcome Measure Information:
Title
Incidence of Device Implantation Success
Description
Incidence of successful implantation of the Aria CV device defined as follows: Absence of investigational device or procedure-related patient death within 7 days post index procedure based on Data Safety Monitoring Board (DSMB) adjudication; Correct positioning of the Aria CV device implantable components at the targeted locations upon completion of index procedure based on imaging; and Aria CV balloon inflates and deflates responding to cyclic pressure changes in the pulmonary artery at time of index procedure, based on imaging.
Time Frame
7 days post-implant
Title
Changes in World Health Organization (WHO) Functional Class
Description
Changes in WHO Functional Class from baseline to 6-month.
Time Frame
6 months post-implant
Title
Changes in 6-Minute Walk Distance
Description
Changes in the 6-minute walk distance from baseline to 6-month.
Time Frame
6 months post-implant
Title
Changes in Modified Borg Dyspnea Score (MBS)
Description
Changes in MBS from baseline to 6-months. MBS is a measure of breathlessness during exercise that ranges from 0 to 10, where 0 is no breathlessness and 10 is maximal breathlessness.
Time Frame
6 months post-implant
Title
Changes in biomarker N-terminal pro hormone BNP (NT-pro-BNP)
Description
Change in N-terminal pro hormone BNP (NT-pro-BNP) from baseline to 6-months.
Time Frame
6 months post-implant
Title
Changes in REVEAL Score
Description
Changes in REVEAL Score 2.0 from baseline to 6-months. The REVEAL 2.0 is a risk calculator for PAH patients that ranges from 0 (lowest risk) to 22 (highest risk).
Time Frame
6 months post-implant
Title
Changes in quality of life as measured by the Living with Pulmonary Hypertension (LPH) questionnaire score
Description
Changes in quality of life from baseline to 6-months as measured by the LPH total score. The Living with Pulmonary Hypertension (LPH) questionnaire has 21 questions each scored on a 6-point scale ranging from 0 (no) to 5 (very much). The LPH total score, calculated by summing scores for the 21 individual questions, ranges from 0 (best) to 105 (worst).
Time Frame
6-months post-implant
Title
Changes in quality of life as measured by the emPHasis-10 questionnaire score
Description
Changes in quality of life from baseline to 6-months as measured by the emPHasis-10 questionnaire score which assesses breathlessness, fatigue, confidence and control. The total score ranges from 0 to 50 with higher scores indicating poorer quality of life.
Time Frame
6-months post-implant
Title
Incidence of Serious Adverse Events
Description
Safety will be evaluated by assessing the incidence of device and/or procedure related SAEs from device implant through last follow up.
Time Frame
24 months post-implant
Title
Changes in pulmonary vascular resistance (PVR)
Description
Changes in PVR (Woods unit) as measured by right heart catheterization from baseline to 6 months.
Time Frame
6 months post-implant
Title
Changes in pulmonary artery pressures (PAPs)
Description
Changes in PAPs (mmHg) as measured by right heart catheterization from baseline to 6 months.
Time Frame
6 months post-implant
Title
Changes in pulmonary capillary wedge pressure (PCWP)
Description
Changes in PCWP (mmHg) as measured by right heart catheterization from baseline to 6 months.
Time Frame
6 months post-implant
Title
Changes in pulmonary arterial compliance
Description
Changes in pulmonary arterial compliance (L/mmHg) as measured by right heart catheterization from baseline to 6 months.
Time Frame
6 months post-implant
Title
Changes in cardiac output (CO) from baseline
Description
Changes in cardiac output (L/Min) as measured by right heart catheterization from baseline to 6 months.
Time Frame
6 months post-implant
Title
Changes in right heart function
Description
Changes in right heart function as measured by echocardiographic imaging.
Time Frame
6 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Common 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 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. Unique Inclusion Criteria for WHO Group I: 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. Unique Inclusion Criteria for WHO Group II: 10. Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) 11. PCWP > 15 mmHg 12. PVR > 3 WU Unique Inclusion Criteria for WHO Group III: 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 Common 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. 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: Required medications (e.g., contrast agents, warfarin, heparin) which cannot be adequately managed; Materials in device including polyurethane, silicone, nickel, and titanium. Ineligible for or refuses blood transfusion. Pregnant, nursing or is planning to become pregnant in the next two years. Life expectancy of less than two years. Currently participating in or planning to participate in other investigational study that may interfere with the outcome of this study. For subject on supplemental oxygen therapy - Subject adheres to the treatment regimen that in the opinion of the physician does not increase subject's safety. Previous diagnosis of cardiac amyloidosis. Unique Exclusion Criteria for WHO Group I: N/A Unique Exclusion Criteria for WHO Group II: Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy - HOCM). Untreated severe aortic or mitral stenosis Diagnosis of heart failure with reduced ejection fraction (HFrEF) Previous diagnosis of nonobstructive hypertrophic cardiomyopathy. Unique Exclusion Criteria for WHO Group III: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caytie Longhenry
Phone
651-200-4891
Email
clonghenry@ariacv.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney Powell
Phone
651-200-4891
Email
spowell@ariacv.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Waxman, M.D.,Ph.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California-Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lloyd Liang
Email
LLLiang@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Richard Channick, M.D.
Facility Name
St. Vincent Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allyn (Ryn) Harker
Email
allyn.harker@ascension.org
First Name & Middle Initial & Last Name & Degree
Ashwin Ravichandran, M.D.
First Name & Middle Initial & Last Name & Degree
Scott Hittinger, M.D.
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Vayer
Email
ovayer@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Eileen Harder, M.D.
First Name & Middle Initial & Last Name & Degree
Aaron Waxman, M.D.
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Teefey, BSN
Email
jon.teefey@beaumont.org
First Name & Middle Initial & Last Name & Degree
Brian Williamson, M.D.
First Name & Middle Initial & Last Name & Degree
Aaron Berman, M.D.
First Name & Middle Initial & Last Name & Degree
Samuel Allen, M.D.
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Peichel, R.N.
Email
gpeichel@umn.edu
First Name & Middle Initial & Last Name & Degree
Thenappan Thenappan, M.D.
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayden Halbach
Email
Halbach.Hayden@mayo.edu
First Name & Middle Initial & Last Name & Degree
Robert Frantz
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Lohmann
Email
jhl4001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Evelyn Horn, M.D.
Facility Name
University of Rochester
City
New York
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Mintz
Email
andrew_mintz@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Jim White, M.D.
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Krabbe
Email
denise.krabbe@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
Susan Reilly
Email
Susan.Reilly@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
Peter Engel, M.D.
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Santiago
Email
Joseph.Santiago@osumc.edu
First Name & Middle Initial & Last Name & Degree
Konstantinos Boudoulas, M.D.
First Name & Middle Initial & Last Name & Degree
Veronica Franco, M.D.
Facility Name
Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Michaud
Email
margaret.michaud@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Lindsay Castle, M.D.
First Name & Middle Initial & Last Name & Degree
Steven Yakubov, M.D.
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Baxley
Email
baxleyr@musc.edu
First Name & Middle Initial & Last Name & Degree
Michelle Esposito, M.D.
Facility Name
Aurora St Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Krueger
Email
kelsey.krueger@aah.org
First Name & Middle Initial & Last Name & Degree
Eric Roberts, M.D.
First Name & Middle Initial & Last Name & Degree
William Fischer, M.D.
First Name & Middle Initial & Last Name & Degree
Tanvir Bajwa, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://ariacv.com/
Description
Information about the Aria CV Pulmonary Hypertension System

Learn more about this trial

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

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