Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
PreVailPH2 OUS
1 other identifier
interventional
20
1 country
3
Brief Summary
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2024
CompletedFirst Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedAugust 1, 2025
July 1, 2025
1.4 years
July 3, 2024
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Device related serious adverse events
Frequency of device related SAEs
30-days post-treatment
Secondary Outcomes (1)
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
6 month post-treatment
Study Arms (1)
PADN with Gradient Denervation System
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Julie Etheridge
Gradient
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 11, 2024
Study Start
June 26, 2024
Primary Completion
November 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share