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New treatment option for Pulmonary Arterial Hypertension
Official title Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
ClinicalTrials.gov ID: NCT04555161
What this study is testing
- What it's testing
- This prospective study is a multi-center early feasibility study assessing the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary hypertension and right heart dysfunction.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Common
- 18 years of age or older.
- Mean pulmonary artery pressure (mPAP) \> 25mmHg.
- Right heart dysfunction as evidence by at least one of the following:
- Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm
You likely can't join if
- Diagnosis of WHO Groups 4 or 5 PH.
- Recent clinical event(s) of any of the following:
- Myocardial infarction or stroke within 6 months prior to the index procedure;
- Sustained tachyarrhythmia (documented heart rate \>110/min) within 2 months prior to the index procedure;
- Uncontrolled, chronic atrial fibrillation.
- Pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that, in the opinion of the investigator...
See the full eligibility criteria
- Common
- 18 years of age or older.
- Mean pulmonary artery pressure (mPAP) \> 25mmHg.
- Right heart dysfunction as evidence by at least one of the following:
- Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm
- RV Fractional area change \< 35%
- RV systolic velocity \< 11.5 cm/s
- RV free wall strain \< 18%
- Lateral tricuspid annulus peak systolic velocity (S') \< 9cm/s
- Pulmonary compliance (C) \< 3.0 ml/mmHg
- Current assessment of WHO FC III or ambulatory IV
- Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT).
- Subject is deemed appropriate for Aria CV device by the Subject Care Team at the investigation site and approved by the Eligibility Review Committee (ERC).
- The subject has agreed to participate in the study by signing the study specific informed consent form.
- The subject agrees to abide by device related travel restrictions. Unique for WHO Group I:
- Pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg
- Pulmonary vascular resistance (PVR) \> 3 Woods Units (WU)
- The subject remains symptomatic despite being on a stable drug regimen of PH specific medication(s) appropriate for their PH classification for at least 90 days prior to planned index procedure. Unique for WHO Group II...
- Diagnosis of WHO Groups 4 or 5 PH.
- Recent clinical event(s) of any of the following:
- Myocardial infarction or stroke within 6 months prior to the index procedure;
- Sustained tachyarrhythmia (documented heart rate \>110/min) within 2 months prior to the index procedure;
- Uncontrolled, chronic atrial fibrillation.
- Pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that, in the opinion of the investigator, may interfere with Aria CV PH System placement or function.
- Any of the following medical history or comorbidities: a. History of endocarditis; b. History of unprovoked Pulmonary Embolism; c. Current renal insufficiency as demonstrated by an eGFR \ 12 mg per day at time of...
- Anatomy is not suitable for placement of Aria CV device.
- Right heart valve regurgitation as follows:
- Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation;
- Severe (Grade 4) tricuspid valve regurgitation.
- Hypersensitivity or contraindication to:
- Required medications (e.g., contrast agents, warfarin, heparin) which cannot be adequately managed;
- Materials in device including polyurethane, silicone, nickel, and titanium.
- Ineligible for or refuses blood transfusion.
- Pregnant, nursing or is planning to become pregnant in the next two years.
- Life expectancy of less than two years.
- Currently participating in or planning to participate in other investigational study that may interfere with the outcome of this study.
- For subject on supplemental oxygen therapy - Subject adheres to the treatment regimen that in the opinion of the physician does not increase subject's safety.
- Previous diagnosis of cardiac amyloidosis. Unique Exclusion Criteria for WHO Group I: N/A Unique Exclusion Criteria for WHO Group II:
- Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy - HOCM).
- Untreated severe aortic or mitral stenosis
- Diagnosis of heart failure with reduced ejection fraction (HFrEF)
- Previous diagnosis of nonobstructive hypertrophic cardiomyopathy. Unique Exclusion Criteria for WHO Group III: N/A
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Charleston, South Carolina, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.