NCT06495970 Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
| NCT ID | NCT06495970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gradient Denervation Technologies |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-26 |
| Primary Completion | 2025-11-30 |
Trial Parameters
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Brief Summary
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
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