750
Participants
Start Date
December 1, 2025
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2031
Pulmonary Artery Denervation (PADN)
"In patients randomized to Intervention, a Contrast pulmonary artery (PA) angiography will be performed to identify the pulmonary artery bifurcation and measure the PA diameter. Once the anatomy is deemed suitable, a radiofrequency ablation catheter will be introduced into the ostium of the left PA and the distal bifurcation of the main PA. The catheter will be maneuvered within the PA to deliver energy circumferentially, ensuring tight electrode contact with the endovascular surface. Approximately three ablations will be performed at a target temperature of 50 °C (range 45-55 °C) for 120 seconds each at both the left PA ostium and the distal main PA bifurcation.~All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)"
Sham procedure control
In patients randomized to a placebo-procedure, a script will be followed for approximately 20 minutes to simulate the PADN procedure. All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)
Pulnovo Medical, Inc.
INDUSTRY