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

Gradient Denervation Technologies

Status: Enrolling

Conditions: Group 2 Pulmonary Hypertension; Heart Failure

Treatments: Device: Gradient Denervation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06052072

CIP-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PADN with Gradient Denervation System

Experimental group

Description:

Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Treatment:

Device: Gradient Denervation System