Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT06495970
Recruiting Not applicable

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

NCT06495970 · tracked via the Priya Life Science Spain tracker
Sponsor
Gradient Denervation Technologies
Phase
Not applicable
Started
2024-06-26
Last updated
2025-08-01

Condition(s) studied

Pulmonary Hypertension

Investigational drug(s) / intervention(s)

Gradient Denervation System

Gradient Denervation System: 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 summary

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

Eligibility

Sex
ALL
Min age
22 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Device related serious adverse events — 30-days post-treatment
    Frequency of device related SAEs

Trial sites (3)

FacilityCityRegionStatus
Hospital Universitari Germans Trias i Pujol Badalona Spain Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Hospital Clínico Universitario de Valencia Valencia Spain Recruiting

Other trials for the same condition

A Study of Mosliciguat in PH-ILD Active, not recruiting
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) Recruiting
Multicenter Study on the Development of Pulmonary Arterial Hypertension Screening Models Based on Artificial Intelligence for Patients With Systemic Sclerosis Recruiting
A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489 Active, not recruiting
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06495970 on ClinicalTrials.gov ↗ ← All trials in Spain