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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06052072

Acronym

PreVail-PH2

Enrollment

Registered

2023-09-25

Start date

2024-02-20

Completion date

2028-07-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group 2 Pulmonary Hypertension, Heart Failure

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.

Interventions

DEVICEGradient Denervation System

Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective, single arm, multi-center, early feasibility study

Eligibility

Sex/Gender

ALL

Age

22 Years to 85 Years

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 1 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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026