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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)

RECRUITINGN/ASponsored by Gradient Denervation Technologies
Actively Recruiting
PhaseN/A
SponsorGradient Denervation Technologies
Started2024-06-26
Est. completion2025-11-30
Eligibility
Age22 Years – 85 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06495970

Summary

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

Eligibility

Age: 22 Years – 85 YearsHealthy volunteers accepted
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

Conditions2

Heart DiseasePulmonary Hypertension

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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