Clinical trial NCT05001711: Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Aria CV, Inc
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 Days
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: 30 Days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Irene M Lang, MD
role: PRINCIPAL_INVESTIGATOR
References: