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

Not Applicable

Recruiting

• Conditions: Heart Failure; Group 2 Pulmonary Hypertension
• Interventions: Device: Gradient Denervation System

• Registration Number: NCT06052072
• Lead Sponsor: Gradient Denervation Technologies

Brief 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

Detailed Description

Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.

Study Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Study Start: 2024-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-09-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• Ambulatory with a Life expectancy of < 1 years
• Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
• Unable to tolerate right heart catheterization
• Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
• Severe aortic, mitral or pulmonary valve regurgitation
• Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy
• Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PADN with Gradient Denervation System	Gradient Denervation System	Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Primary Outcome Measures

Name	Time	Method
Device related serious adverse events	Through 30 days post-treatment	Frequency of SAEs deemed to be related to the investigational device and/or procedure.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Aurora Health; 🇺🇸 Milwaukee, Wisconsin, United States