Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gradient Denervation System.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension. Basic parameters: 22 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Detailed description
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.
Interventions
- Device 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.
Primary outcome measures
- Device related serious adverse events [Time frame: 30-days post-treatment]
Secondary outcome measures (1)
- Mean change from baseline in Pulmonary Vascular Resistance (woods units) [Time frame: 6 month post-treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 3 centers
- Hospital Universitari Germans Trias i Pujol — Badalona
- Hospital Universitari Vall d'Hebron — Barcelona
- Hospital Clínico Universitario de Valencia — Valencia
Identifiers
NCT: NCT06495970 · CIP-003