Pulmonary HypertensionNCT05001711

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

A study testing Aria CV Acute PH System in people with Pulmonary Hypertension, run by Aria CV, Inc at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Hypertension
What is being tested?: Aria CV Acute PH System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteAustria
Study dates: 12 Jul 2021to 6 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years or older
Symptomatic WHO Functional Class (FC) III
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:
Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm
RV Fractional area change <35%
RVs' velocity < 10 cm/s

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RV free wall strain <18%
RVEF < 35% by visual estimate
MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months.
Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) > 30 mmHg
Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting RHC: mPAP > 30 mmHg
Patient is willing and able to provide informed consent.
Previous diagnosis of left heart dysfunction.
Intra-procedural confirmation of WHO Group 2 diagnosis based on resting RHC:
PAWP: >15 and ≤30 mmHg, and
Combined post- and pre-capillary pulmonary hypertension (CpcPH), defined as PVR > 3 WU
18 years or older
Symptomatic WHO Functional Class (FC) III
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:
Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm
RV Fractional area change <35%
RVs' velocity < 10 cm/s
RV free wall strain <18%
RVEF < 35% by visual estimate
MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months
Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) > 30 mmHg
Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting RHC: mPAP > 30 mmHg
Patient is willing and able to provide informed consent
Previous diagnosis of chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis
Intra-procedural confirmation of WHO Group 3 diagnosis based on resting RHC:
PAWP≤ 15 mmHg, and
PVR > 4 WU

Who cannot join

Anatomy not suitable for RHC
Anatomy not suitable for placement of Aria CV Acute Device:
Contraindication to 16 Fr femoral vein access
Body habitus that would preclude safe placement of any components of Aria CV Acute Device
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
Uncontrolled atrial fibrillation

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Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure
Right heart valve regurgitation:
Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation
Severe (Grade 4) tricuspid valve regurgitation
Patient with any of the following medical history or comorbidities:
History of unprovoked Pulmonary Embolism or CTEPH
Currently on dialysis
Current or recent (<6 months prior to planned index procedure) endocarditis
Clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt
Current active systemic infection requiring antibiotic therapy
As determined by the physician the subject is medically unstable and/or represents an unreasonable procedural risk.
Hypersensitivity or contraindication to
Required medications (e.g. contrast agents, heparin) which cannot be adequately managed, or
Materials in investigational device including polyurethane, silicone, nickel, and titanium
Pregnant or lactating woman
Currently participating in other investigational drug or device trials that may interfere with the outcome of this study
Diagnosis of WHO Groups 1, 3, 4 or 5 PH
Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy-HOCM)
Untreated aortic or mitral stenosis
Anatomy not suitable for RHC
Anatomy not suitable for placement of Aria CV Acute Device:
Contraindication to 16 Fr femoral vein access
Body habitus that would preclude safe placement of any components of Aria CV Acute device
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
Uncontrolled atrial fibrillation
Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure
Right heart valve regurgitation:
Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation
Severe (Grade 4) tricuspid valve regurgitation
Patient with any of the following medical history or comorbidities:
History of unprovoked Pulmonary Embolism or CTEPH
Currently on dialysis
Current or recent (<6 months prior to planned index procedure) endocarditis
Clinically significant shunt such as patent foramen ovale, inter-atrial or inter-ventricular shunt, or other.
Current active systemic infection requiring antibiotic therapy
As determined by the physician the subject is medically unstable and/or represents an unreasonable procedural risk.
Hypersensitivity or contraindication to
Required medications (e.g. contrast agents, warfarin, heparin) which cannot be adequately managed, or
Materials in investigational device including polyurethane, silicone, nickel, and titanium.
Pregnant or lactating woman
Currently participating in other investigational drug or device trials that may interfere with the outcome of this study
Diagnosis of WHO Groups 1, 2, 4 or 5 PH

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna

Other trials in Austria

About this study

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

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.

Read the 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.

Conditions: Pulmonary Hypertension
Being tested: Aria CV Acute PH System
Medical subject headings: Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aria CV Acute PH SystemDevice
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.

Study groups in NCT05001711
Study group	Role	What they receive
WHO Group 2	Experimental	Not described Receives: Device: Aria CV Acute PH System
WHO Group 3	Experimental	Not described Receives: Device: Aria CV Acute PH System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Secondary Safety Endpoint
All reported adverse events occurring during the study will be summarized by the CEC for seriousness and relatedness based on site-reported data.
Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 20216 Jan 2022

First posted12 Aug 2021
Study start12 Jul 2021
Primary completion30 Dec 2021
Study completion6 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05001711
Sponsor's protocol ID: ARIACV202101
Status last verified: Mar 2024
First submitted: 26 Jul 2021
Last updated: 20 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

All Pulmonary Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05001711
Acronym / sponsor ID: ARIACV202101
Conditions: Pulmonary Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Aria CV, IncIndustry (pharma, biotech, devices)
Study start: 12 Jul 2021 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 6 Jan 2022 (actual)
First posted: 12 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
WHO Group 2	Experimental	Device: Aria CV Acute PH System
WHO Group 3	Experimental	Device: Aria CV Acute PH System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (32 listed)

18 years or older
Symptomatic WHO Functional Class (FC) III
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:
MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months.
Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) > 30 mmHg

Key exclusion criteria (48 listed)

Anatomy not suitable for RHC
Anatomy not suitable for placement of Aria CV Acute Device:
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
Uncontrolled atrial fibrillation
Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aria CV Acute PH SystemThe 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.	Device	WHO Group 2, WHO Group 3

Primary outcome

Primary Safety Endpoint
Time frame: 30 Days
Incidence of investigational device-related serious adverse events (SAEs) through 30 days post-index procedure, based on Clinical Events Committee assessment.

1 secondary outcome

Secondary Safety Endpoint
Time frame: 30 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.

Related trials for Pulmonary Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Irene M Lang, MD principal investigator

Medical University of Vienna

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aria CV Acute PH System in people with Pulmonary Hypertension, run by Aria CV, Inc at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001711.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.