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PreVail-PH2 Study: Pulmonary Artery Denervation for Heart Failure with Pulmonary Hypertension

This study is looking at a new procedure called pulmonary artery denervation (PADN) using the Gradient Denervation System. This procedure uses ultrasound to treat nerves in the pulmonary artery (the main artery from the heart to the lungs) for people with heart failure and Group 2 pulmonary hypertension (high blood pressure in the lungs). The study aims to see if this treatment can improve your quality of life. To join, you need to be between 22 and 85 years old, have heart failure with an ejection fraction (a measure of how well your heart pumps) of 40% or more, and specific measurements of pressure and resistance in your pulmonary artery. The main goal is to track any serious problems related to the device for 30 days after the procedure. This study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for device-related serious adverse events through 30 days post-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06052072

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Enrolling by Invitation
NAAges 22–85InterventionalTreatment
Gradient Denervation Technologies
~50 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Gradient Denervation System

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device related serious adverse events
Measured over Through 30 days post-treatment

Conditions

Group 2 Pulmonary Hypertension
Heart Failure

Explore related trials

Heart FailurePulmonary Hypertension

Where it's being run

8 sites across 6 states
Texas2
Wisconsin2
Illinois1
Massachusetts1
North Carolina1
South Carolina1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Heart Failure with EF ≥ 40% (by TTE within last 3 months)
Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
Cardiac index (CI) ≥ 1.7 L/min/m2
NYHA Class II or III
Glomerular Filtration Rate (GFR) ≥ 25 ml/min
Stable, guideline directed medical treatment, including controlled volume status for a minimum of 1 months prior treatment

Exclusion

Ambulatory with a Life expectancy of \< 1 years
Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
Unable to tolerate right heart catheterization
Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
Severe aortic, mitral or pulmonary valve regurgitation
Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy
Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)

What this trial measures

  • Device related serious adverse eventsThrough 30 days post-treatment

    Frequency of SAEs deemed to be related to the investigational device and/or procedure.