Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This early feasibility study is intended to 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:
• Heart Failure with EF ≥ 40% (by TTE within last 3 months)
• 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
• Cardiac index (CI) ≥ 1.7 L/min/m2
• NYHA Class II or III
• Glomerular Filtration Rate (GFR) ≥ 25 ml/min
• Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
Duke University
RECRUITING
Durham
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Baylor College of Medicine
RECRUITING
Houston
Houston Methodist
RECRUITING
Houston
Wisconsin
University of Wisconsin
RECRUITING
Madison
Aurora Health
RECRUITING
Milwaukee
Contact Information
Primary
Jason McCarthy
clinical@gradientdenervation.com
763-657-7036
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 30
Treatments
Experimental: PADN with Gradient Denervation System
Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Related Therapeutic Areas
Sponsors
Leads: Gradient Denervation Technologies