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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-06-26 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Julie Etheridge
STUDY DIRECTOR
Gradient
Frequently Asked Questions
Who can join the NCT06495970 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 85 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06495970 currently recruiting?
Yes, NCT06495970 is actively recruiting participants. Contact the research team at clinical@gradientdenervation.com for enrollment information.
Where is the NCT06495970 trial being conducted?
This trial is being conducted at Badalona, Spain, Barcelona, Spain, Valencia, Spain.
Who is sponsoring the NCT06495970 clinical trial?
NCT06495970 is sponsored by Gradient Denervation Technologies. The principal investigator is Julie Etheridge at Gradient. The trial plans to enroll 20 participants.