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Device

Aria CV System for Pulmonary Arterial Hypertension (ASPIRE PH Trial)

N/A
Recruiting
Led By Aaron Waxman, M.D.,Ph.D.
Research Sponsored by Aria CV, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, PCWP ≤ 15mmHg, PVR >4 WU (for WHO Group III)
Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) (for WHO Group II)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-implant
Awards & highlights

ASPIRE PH Trial Summary

This trial tests if a new device is safe & effective for people with lung & heart problems.

Who is the study for?
Adults with pulmonary hypertension and right heart dysfunction who still have symptoms despite taking specific medications for at least 90 days. They must not have certain severe heart conditions, recent major cardiovascular events, or other health issues that could interfere with the trial's device.Check my eligibility
What is being tested?
The Aria CV Pulmonary Hypertension System is being tested in this study to see if it's safe and works well for patients with pulmonary hypertension and problems with the right side of their heart.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications related to device implantation, reactions to materials in the device, or issues from required medications like blood thinners.

ASPIRE PH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a lung condition like COPD or fibrosis, but my heart and lung pressures are within specific limits.
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I have been diagnosed with heart failure but my heart still pumps well.
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I have right heart dysfunction and meet specific criteria for a heart device study.
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I am 18 years old or older.

ASPIRE PH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs).
Secondary outcome measures
Changes in 6-Minute Walk Distance
Changes in Modified Borg Dyspnea Score (MBS)
Changes in REVEAL Score
+12 more

ASPIRE PH Trial Design

1Treatment groups
Experimental Treatment
Group I: Aria CV Pulmonary Hypertension SystemExperimental Treatment1 Intervention
Treatment with the Aria CV Pulmonary Hypertension System

Find a Location

Who is running the clinical trial?

Aria CV, IncLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Aaron Waxman, M.D.,Ph.D.Principal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
2021. "Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04555161.
All > Pulmonary Arterial Hypertension > Pulmonary Hypertension
~4 spots leftby Oct 2024
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