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)
ConditionsPulmonary Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Hypertension
- Sponsor
- Gradient Denervation Technologies
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Device related serious adverse events
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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 catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.
Investigators
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
Outcomes
Primary Outcomes
Device related serious adverse events
Time Frame: 30-days post-treatment
Frequency of device related SAEs
Secondary Outcomes
- Mean change from baseline in Pulmonary Vascular Resistance (woods units)(6 month post-treatment)
Study Sites (3)
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