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NCT Number: NCT06495970

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

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gradient Denervation System

Device

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.

Primary outcomes

  1. Device related serious adverse events

    Time frame: 30-days post-treatment

    Frequency of device related SAEs

Secondary outcomes

  1. Mean change from baseline in Pulmonary Vascular Resistance (woods units)

    Time frame: 6 month post-treatment

    Calculated percent mean change from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Etheridge

CONTACT

[email protected]

+49 16094434355

Sponsors and collaborators

Lead sponsor

Gradient Denervation Technologies

Industry

Registry information

Acronym: PreVailPH2 OUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 11, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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