Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension

Sponsor
Aria CV, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05001711
Collaborator
(none)
40
1
2
17.6
2.3

Study Details

Study Description

Brief Summary

This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.

Condition or Disease Intervention/Treatment Phase
  • Device: Aria CV Acute PH System
N/A

Detailed Description

This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.

The planned enrollment is a maximum enrollment of 40 patients to ensure up to 10 "Device Deployed" subjects in each arm at one site.

The duration of study participation for each subject is expected to be approximately 60 days.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Acute Feasibility Study Assessing Safety and Performance of Aria CV Acute PH System in Patients With WHO Group 2 and 3 Pulmonary Hypertension
Actual Study Start Date :
Jul 12, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: WHO Group 2

Device: Aria CV Acute PH System
The Aria CV Acute PH System is indicated for evaluation of hemodynamic responses (e.g. pulmonary arterial compliance, cardiac output, and effective arterial elastance) to an intravascular Balloon catheter temporarily placed in the pulmonary artery in symptomatic adult patients with WHO Group 2 or WHO Group 3 pulmonary hypertension and right ventricular dysfunction.

Experimental: WHO Group 3

Device: Aria CV Acute PH System
The Aria CV Acute PH System is indicated for evaluation of hemodynamic responses (e.g. pulmonary arterial compliance, cardiac output, and effective arterial elastance) to an intravascular Balloon catheter temporarily placed in the pulmonary artery in symptomatic adult patients with WHO Group 2 or WHO Group 3 pulmonary hypertension and right ventricular dysfunction.

Outcome Measures

Primary Outcome Measures

  1. Primary Safety Endpoint [30 Days]

    Incidence of investigational device-related serious adverse events (SAEs) through 30 days post-index procedure, based on Clinical Events Committee assessment.

Secondary Outcome Measures

  1. Secondary Safety Endpoint [30 Days]

    All reported adverse events occurring during the study will be summarized by the CEC for seriousness and relatedness based on site-reported data.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria for WHO Group 2

  1. 18 years or older

  2. Symptomatic WHO Functional Class (FC) III

  3. Based on preexisting echocardiography within the past 6 months, evidence of right heart dysfunction: RV ejection fraction (RVEF) < 45% by visual estimate, and at least one of the following:

  4. Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm

  5. RV Fractional area change <35%

  6. RVs' velocity < 10 cm/s

  7. RV free wall strain <18%

  8. RVEF < 35% by visual estimate

  9. MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months.

  10. Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) > 30 mmHg

  11. Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting RHC: mPAP > 30 mmHg

  12. Patient is willing and able to provide informed consent.

  13. Previous diagnosis of left heart dysfunction.

  14. Intra-procedural confirmation of WHO Group 2 diagnosis based on resting RHC:

  15. PAWP: >15 and ≤30 mmHg, and

  16. Combined post- and pre-capillary pulmonary hypertension (CpcPH), defined as PVR > 3 WU

Exclusion Criteria for WHO Group 2

  1. Anatomy not suitable for RHC

  2. Anatomy not suitable for placement of Aria CV Acute Device:

  3. Contraindication to 16 Fr femoral vein access

  4. Body habitus that would preclude safe placement of any components of Aria CV Acute Device

  5. Any previous tricuspid valvular surgery, percutaneous valve repair, or presence of prosthetic cardiac device such as pacemaker or defibrillator leads, or vena cava filter that in the opinion of the investigator may interfere with investigational device placement or performance

  6. Uncontrolled atrial fibrillation

  7. Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure

  8. Right heart valve regurgitation:

  9. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation

  10. Severe (Grade 4) tricuspid valve regurgitation

  11. Patient with any of the following medical history or comorbidities:

  12. History of unprovoked Pulmonary Embolism or CTEPH

  13. Currently on dialysis

  14. Current or recent (<6 months prior to planned index procedure) endocarditis

  15. Clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt

  16. Current active systemic infection requiring antibiotic therapy

  17. As determined by the physician the subject is medically unstable and/or represents an unreasonable procedural risk.

  18. Hypersensitivity or contraindication to

  19. Required medications (e.g. contrast agents, heparin) which cannot be adequately managed, or

  20. Materials in investigational device including polyurethane, silicone, nickel, and titanium

  21. Pregnant or lactating woman

  22. Currently participating in other investigational drug or device trials that may interfere with the outcome of this study

  23. Diagnosis of WHO Groups 1, 3, 4 or 5 PH

  24. Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy-HOCM)

  25. Untreated aortic or mitral stenosis

Inclusion Criteria for WHO Group 3

  1. 18 years or older

  2. Symptomatic WHO Functional Class (FC) III

  3. Based on preexisting echocardiography within the past 6 months, evidence of right heart dysfunction: RV ejection fraction (RVEF) < 45% by visual estimate, and at least one of the following:

  4. Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm

  5. RV Fractional area change <35%

  6. RVs' velocity < 10 cm/s

  7. RV free wall strain <18%

  8. RVEF < 35% by visual estimate

  9. MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months

  10. Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) > 30 mmHg

  11. Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting RHC: mPAP > 30 mmHg

  12. Patient is willing and able to provide informed consent

  13. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis

  14. Intra-procedural confirmation of WHO Group 3 diagnosis based on resting RHC:

  15. PAWP≤ 15 mmHg, and

  16. PVR > 4 WU

Exclusion Criteria for WHO Group 3

  1. Anatomy not suitable for RHC

  2. Anatomy not suitable for placement of Aria CV Acute Device:

  3. Contraindication to 16 Fr femoral vein access

  4. Body habitus that would preclude safe placement of any components of Aria CV Acute device

  5. Any previous tricuspid valvular surgery, percutaneous valve repair, or presence of prosthetic cardiac device such as pacemaker or defibrillator leads, or vena cava filter that in the opinion of the investigator may interfere with investigational device placement or performance

  6. Uncontrolled atrial fibrillation

  7. Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure

  8. Right heart valve regurgitation:

  9. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation

  10. Severe (Grade 4) tricuspid valve regurgitation

  11. Patient with any of the following medical history or comorbidities:

  12. History of unprovoked Pulmonary Embolism or CTEPH

  13. Currently on dialysis

  14. Current or recent (<6 months prior to planned index procedure) endocarditis

  15. Clinically significant shunt such as patent foramen ovale, inter-atrial or inter-ventricular shunt, or other.

  16. Current active systemic infection requiring antibiotic therapy

  17. As determined by the physician the subject is medically unstable and/or represents an unreasonable procedural risk.

  18. Hypersensitivity or contraindication to

  19. Required medications (e.g. contrast agents, warfarin, heparin) which cannot be adequately managed, or

  20. Materials in investigational device including polyurethane, silicone, nickel, and titanium.

  21. Pregnant or lactating woman

  22. Currently participating in other investigational drug or device trials that may interfere with the outcome of this study

  23. Diagnosis of WHO Groups 1, 2, 4 or 5 PH

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria

Sponsors and Collaborators

  • Aria CV, Inc

Investigators

  • Principal Investigator: Irene M Lang, MD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aria CV, Inc
ClinicalTrials.gov Identifier:
NCT05001711
Other Study ID Numbers:
  • ARIACV202101
First Posted:
Aug 12, 2021
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022