Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGHospital Clínico Universitario de Valencia
Valencia, Spain
RECRUITINGDevice related serious adverse events
Frequency of device related SAEs
Time frame: 30-days post-treatment
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Calculated percent mean change from baseline
Time frame: 6 month post-treatment
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