Is NCT04555161 recruiting in Boston, MA?

Yes, NCT04555161 is currently recruiting participants at its Boston, MA location. This pulmonary arterial hypertension clinical trial is actively enrolling qualified participants.

How do I join the pulmonary arterial hypertension clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pulmonary Arterial Hypertension Clinical Trial in Boston, MA

Who Can Participate

Inclusion Criteria

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 Inclusion Criteria 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 Inclusion Criteria for WHO Group II: 10\. Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) 11. PCWP \> 15 mmHg 12. PVR \> 3 WU Unique Inclusion Criteria for WHO Group III: 10\. Previous diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis. 11\. PCWP ≤ 15mmHg 12. PVR \>4 WU Common

Exclusion Criteria

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 \< 30 mL/min/1.73 m2 or end stage renal disease requiring chronic dialysis; d. Current diagnosis of scleroderma associated with: i. Any history of GI bleeding or receiving iron infusions within 2 years prior to enrollment; ii. Significant skin involvement that could compromise daily activities or the ability to receive IV medications, or sclerodactyly that causes surface ulcerations, digital ulcerations, or ulcerating calcinosis lesions. e. History of receiving immunosuppressant therapy as follows: i. Excluded if receiving Mycophenolate mofetil within 30 days prior to enrollment, or Rituximab within 6 months prior to enrollment, or currently receiving Prednisone at a dose \> 12 mg per day at time of enrollment; ii. Excluded if any immunosuppressant other than Mycophenolate mofetil, Rituximab or Prednisone, per above. e. Current pulmonary veno-occlusive disease (PVOD); f. Current pulmonary capillary hemangiomatosis (PCH); g. History of clinically significant patent foramen ovale (PFO) or other inter-atrial or inter-ventricular shunt; h. History of gastric antral vascular ectasia (GAVE), gastrointestinal or intracranial bleeding which, in the opinion of the investigator, will predispose subject to major bleeding events following Aria CV device placement and warfarin anticoagulation regimen; i. Active infection requiring antibiotic therapy within two (2) weeks of procedure; j. Blood dyscrasias that may, in the opinion of investigator(s), expose subject to unacceptable procedural risks such as severe or worsening leukopenia, anemia, thrombocytopenia, untreated iron deficiency or history of bleeding diathesis or coagulopathy.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04555161) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pulmonary Arterial Hypertension Treatment Options in Boston, MA

If you're searching for pulmonary arterial hypertension treatment options in Boston, MA, this clinical trial (NCT04555161) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pulmonary arterial hypertension specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pulmonary arterial hypertension clinical trials near you to find additional studies recruiting in your area.

Pulmonary Arterial Hypertension Clinical Trial in Boston, MA

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