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
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
• NYHA Class II or III
• Glomerular Filtration Rate (GFR) ≥ 25 ml/min
Locations
Other Locations
Spain
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Julie Etheridge
clinical@gradientdenervation.com
+49 16094434355
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Experimental: PADN with Gradient Denervation System
Related Therapeutic Areas
Sponsors
Leads: Gradient Denervation Technologies