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Trial record 1 of 2 for:    Aria CV, Inc
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Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH)

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ClinicalTrials.gov Identifier: NCT04555161
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Aria CV, Inc

Tracking Information
First Submitted Date  ICMJE August 31, 2020
First Posted Date  ICMJE September 18, 2020
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
Primary Safety Endpoint is the incidence of device- or procedure-related serious adverse events. [ Time Frame: 30 days post-implant ]
The primary safety endpoint is the incidence of investigational device- or procedure-related serious adverse events through 30 days post-index procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • Incidence of Device Success [ Time Frame: 7 days post-implant ]
    Incidence of successful implantation of the Aria CV device defined as follows:
    1. Absence of investigational device or procedure-related patient death within 7 days post index procedure based on Data Safety Monitoring Board (DSMB) adjudication;
    2. Correct positioning of the Aria CV device implantable components at the targeted locations upon completion of index procedure based on imaging; and
    3. 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 from baseline [ Time Frame: 6 months post-implant ]
    Changes in WHO Functional Class from baseline to 6-month
  • Changes in 6-Minute Walk Distance from baseline [ Time Frame: 6 months post-implant ]
    Changes in the 6-minute walk distance from baseline to 6-month as measured in meters.
  • Changes in Modified Borg Dyspnea Score (MBS) from baseline [ Time Frame: 6 months post-implant ]
    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 N-terminal (NT)-pro hormone BNP (NT-pro-BNP) from baseline [ Time Frame: 6 months post-implant ]
    Change in N-terminal (NT)-pro hormone BNP (NT-pro-BNP) from baseline to 6-months
  • Changes in REVEAL Score from baseline [ Time Frame: 6 months post-implant ]
    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) score from baseline [ Time Frame: 6-months post-implant ]
    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 score from baseline [ Time Frame: 6-months post-implant ]
    Changes in quality of life from baseline to 6-months as measured by the emPHasis-10 score which assesses breathlessness, fatigue, confidence and control. It ranges from 0 to 50 with higher scores indicating poor quality of life.
  • Incidence of Adverse Events [ Time Frame: 24 months post-implant ]
    Incidence of adverse events will be summarized by seriousness and relatedness reported for the duration of the study.
  • Changes in pulmonary vascular resistance (PVR) from baseline [ Time Frame: 6 months post-implant ]
    Changes in PVR (Woods unit) as measured by right heart catheterization from baseline to 6 months.
  • Changes in pulmonary artery pressure (PAP) from baseline [ Time Frame: 6 months post-implant ]
    Changes in PAP (mmHg) as measured by right heart catheterization from baseline to 6 months
  • Changes in pulmonary capillary wedge (PCWP) pressure from baseline [ Time Frame: 6 months post-implant ]
    Changes in PCWP (mmHG) as measured by right heart catheterization from baseline to 6 months
  • Changes in pulmonary arterial compliance from baseline [ Time Frame: 6 months post-implant ]
    Changes in pulmonary arterial compliance (L/mmHg) as measured by right heart catheterization from baseline to 6 months
  • Changes in Pulmonary effective arterial elastance from baseline [ Time Frame: 6 months post-implant ]
    Changes in pulmonary effective arterial elastance (mmHg/L) as derived from right heart catheterization from baseline to 6 months
  • Changes in cardiac output (CO) from baseline [ Time Frame: 6 months post-implant ]
    Changes in cardiac output (L/Min) as measured by right heart catheterization from baseline to 6 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
Official Title  ICMJE An Early Feasibility Study Assessing Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
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 arterial hypertension.
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 arterial hypertension (PAH). 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 PAH.

The study will be conducted in a maximum of 10 centers in the United States with a planned maximum enrollment of 45 patients to ensure up to 15 "Device Deployed" subjects. Patients will be evaluated at each of the following time intervals: preoperative, implant, 7-day (or discharge if earlier) and 1-, 3-, 6-, 12- and 24-month post index procedure. The Aria CV PH System will be assessed at each follow-up visit, as well as at 2- and 9- month and quarterly between 12 and 24 months. The duration of the study is anticipated to be 2.5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a single-arm, non-randomized early feasibility study to evaluate the feasibility and safety of the Aria CV PH System in patients with pulmonary arterial hypertension.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
Intervention  ICMJE Device: Aria CV Pulmonary Hypertension System
The Aria CV PH System is indicated for the treatment of adult patients with World Health Organization (WHO) Group I Pulmonary Arterial Hypertension who remain symptomatic despite treatment with optimal medical therapy.
Other Name: Aria CV PH System
Study Arms  ICMJE Experimental: Aria CV Pulmonary Hypertension System
Treatment with the Aria CV Pulmonary Hypertension System
Intervention: Device: Aria CV Pulmonary Hypertension System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  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 a serum creatinine > 2.0 mg/dL or end stage renal disease requiring chronic dialysis;
    3. Current scleroderma, or other collagen vascular disease treated with immuno-suppressant;
    4. Current pulmonary veno-occlusive disease (PVOD);
    5. Current pulmonary capillary hemangiomatosis (PCH);
    6. History of clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt;
    7. 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;
    8. Current active systemic infection requiring antibiotic therapy;
    9. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Steinbrink 1-651-200-4891 msteinbrink@ariacv.com
Contact: Rich Schroeder rschroeder@ariacv.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04555161
Other Study ID Numbers  ICMJE ASPIREPH202001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aria CV, Inc
Study Sponsor  ICMJE Aria CV, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aaron Waxman, M.D.,Ph.D. Brigham and Women's Hospital
PRS Account Aria CV, Inc
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP