Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
NCT ID: NCT06052072
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-02-20
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PADN with Gradient Denervation System
Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Gradient Denervation System
Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Interventions
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Gradient Denervation System
Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Eligibility Criteria
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Inclusion Criteria
* 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 3 months prior treatment
Exclusion Criteria
* 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)
22 Years
85 Years
ALL
No
Sponsors
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Gradient Denervation Technologies
INDUSTRY
Responsible Party
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Locations
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Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Aurora Health
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP-002
Identifier Type: -
Identifier Source: org_study_id