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)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.6
• Patients Per Site Per Month: 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
Pulmonary Hypertension	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: Hypertension, Pulmonary; Hypertension

Study Results

No Results Posted as of Mar 16, 2022