- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001711
Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension
Acute Feasibility Study Assessing Safety and Performance of Aria CV Acute PH System in Patients With WHO Group 2 and 3 Pulmonary Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rachel Currie, MPH
- Phone Number: 651-200-4892
- Email: rcurrie@ariacv.com
Study Locations
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-
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Vienna, Austria
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for WHO Group 2
- 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 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
Exclusion Criteria for WHO Group 2
- 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 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
Inclusion Criteria for WHO Group 3
- 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
Exclusion Criteria for WHO Group 3
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WHO Group 2
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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.
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Experimental: WHO Group 3
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Safety Endpoint
Time Frame: 30 Days
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Incidence of investigational device-related serious adverse events (SAEs) through 30 days post-index procedure, based on Clinical Events Committee assessment.
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30 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Safety Endpoint
Time Frame: 30 Days
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All reported adverse events occurring during the study will be summarized by the CEC for seriousness and relatedness based on site-reported data.
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30 Days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irene M Lang, MD, Medical University of Vienna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARIACV202101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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