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Clinical Trials in the USA / NCT06052072
Enrolling by invitation Not applicable

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

NCT06052072 · tracked via the Priya Life Science USA tracker
Sponsor
Gradient Denervation Technologies
Phase
Not applicable
Started
2024-02-20
Last updated
2026-09-21

Condition(s) studied

Group 2 Pulmonary HypertensionHeart Failure

Investigational drug(s) / intervention(s)

Gradient Denervation System

Gradient Denervation System: Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Study summary

This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Eligibility

Sex
ALL
Min age
22 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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)

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Northwestern University Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Duke University Durham North Carolina
Medical University of South Carolina Charleston South Carolina
Baylor College of Medicine Houston Texas
Houston Methodist Houston Texas
University of Wisconsin Madison Wisconsin
Aurora Health Milwaukee Wisconsin

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06052072 on ClinicalTrials.gov ↗ ← All trials in the USA