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Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

RecruitingNAAges 22 Years - 85 YearsAllGradient Denervation Technologies
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In plain words

What the trial is, and whether it could suit you

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Gradient Denervation System
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Where

3 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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