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Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Sponsor: Gradient Denervation Technologies
Summary
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Key Details
Gender
All
Age Range
22 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-06-26
Completion Date
2026-06-30
Last Updated
2025-08-01
Healthy Volunteers
No
Conditions
Interventions
Gradient Denervation System
The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.
Locations (3)
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain