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

Not Applicable

Recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT06495970
• Lead Sponsor: Gradient Denervation Technologies

Brief 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.

Study Timeline

• Study Start: 2024-06-26
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-11-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• Unwilling to provide informed consent or complete follow-up assessments
• Life expectancy of < 2 years
• Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
• Unable to tolerate right heart catheterization
• Severe aortic, mitral or pulmonary valve regurgitation
• Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
• Systemic infection or localized infection/rash at planned access site at time of procedure
• CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Device related serious adverse events	30-days post-treatment	Frequency of device related SAEs

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Pulmonary Vascular Resistance (woods units)	6 month post-treatment	Calculated percent mean change from baseline

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain