NCT06495970

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Gradient Denervation Technologies · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Detailed description

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-06-26
• Primary completion: 2025-11-30
• Completion: 2026-06-30
• First posted: 2024-07-11
• Last updated: 2025-08-01

Locations

3 sites across 1 country: Spain