Eligibility |
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:
1. Tricuspid Annulus Plane Systolic Excursion (TAPSE) =16 mm
2. RV Fractional area change <35%
3. RVs' velocity < 10 cm/s
4. RV free wall strain <18%
5. RVEF < 35% by visual estimate
4. MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy,
echocardiography, computerized tomography, or magnetic resonance imaging within the
past 6 months.
5. Elevated pulmonary arterial pressure based on preexisting resting RHC within the past
6 months: Mean PAP (mPAP) > 30 mmHg
6. Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting
RHC: mPAP > 30 mmHg
7. Patient is willing and able to provide informed consent.
8. Previous diagnosis of left heart dysfunction.
9. Intra-procedural confirmation of WHO Group 2 diagnosis based on resting RHC:
1. PAWP: >15 and =30 mmHg, and
2. 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:
1. Contraindication to 16 Fr femoral vein access
2. Body habitus that would preclude safe placement of any components of Aria CV
Acute Device
3. 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
4. Uncontrolled atrial fibrillation
5. Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure
6. Right heart valve regurgitation:
1. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation
2. Severe (Grade 4) tricuspid valve regurgitation
7. Patient with any of the following medical history or comorbidities:
1. History of unprovoked Pulmonary Embolism or CTEPH
2. Currently on dialysis
3. Current or recent (<6 months prior to planned index procedure) endocarditis
4. Clinically significant patent foramen ovale or other inter-atrial or
inter-ventricular shunt
5. Current active systemic infection requiring antibiotic therapy
8. As determined by the physician the subject is medically unstable and/or represents an
unreasonable procedural risk.
9. Hypersensitivity or contraindication to
1. Required medications (e.g. contrast agents, heparin) which cannot be adequately
managed, or
2. Materials in investigational device including polyurethane, silicone, nickel, and
titanium
10. Pregnant or lactating woman
11. Currently participating in other investigational drug or device trials that may
interfere with the outcome of this study
12. Diagnosis of WHO Groups 1, 3, 4 or 5 PH
13. Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as
hypertrophic obstructive cardiomyopathy-HOCM)
14. 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:
1. Tricuspid Annulus Plane Systolic Excursion (TAPSE) =16 mm
2. RV Fractional area change <35%
3. RVs' velocity < 10 cm/s
4. RV free wall strain <18%
5. RVEF < 35% by visual estimate
4. MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy,
echocardiography, computerized tomography, or magnetic resonance imaging within the
past 6 months
5. Elevated pulmonary arterial pressure based on preexisting resting RHC within the past
6 months: Mean PAP (mPAP) > 30 mmHg
6. Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting
RHC: mPAP > 30 mmHg
7. Patient is willing and able to provide informed consent
8. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or interstitial
lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema
with fibrosis
9. Intra-procedural confirmation of WHO Group 3 diagnosis based on resting RHC:
1. PAWP= 15 mmHg, and
2. 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:
1. Contraindication to 16 Fr femoral vein access
2. Body habitus that would preclude safe placement of any components of Aria CV
Acute device
3. 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
4. Uncontrolled atrial fibrillation
5. Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure
6. Right heart valve regurgitation:
1. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation
2. Severe (Grade 4) tricuspid valve regurgitation
7. Patient with any of the following medical history or comorbidities:
1. History of unprovoked Pulmonary Embolism or CTEPH
2. Currently on dialysis
3. Current or recent (<6 months prior to planned index procedure) endocarditis
4. Clinically significant shunt such as patent foramen ovale, inter-atrial or
inter-ventricular shunt, or other.
5. Current active systemic infection requiring antibiotic therapy
8. As determined by the physician the subject is medically unstable and/or represents an
unreasonable procedural risk.
9. Hypersensitivity or contraindication to
1. Required medications (e.g. contrast agents, warfarin, heparin) which cannot be
adequately managed, or
2. Materials in investigational device including polyurethane, silicone, nickel, and
titanium.
10. Pregnant or lactating woman
11. Currently participating in other investigational drug or device trials that may
interfere with the outcome of this study
12. Diagnosis of WHO Groups 1, 2, 4 or 5 PH
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