Status:
RECRUITING
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Lead Sponsor:
Gradient Denervation Technologies
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
22-85 years
Phase:
NA
Brief Summary
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 cath...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06495970
Start Date
June 26 2024
End Date
June 30 2026
Last Update
August 1 2025
Active Locations (3)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
2
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
3
Hospital Clínico Universitario de Valencia
Valencia, Spain