NCT06495970Recruiting
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 26 Jun 2024
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Gradient Denervation Technologies
- NCT number
- NCT06495970
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 26 Jun 2024 to the primary completion date, 30 Nov 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- Unable to tolerate right heart catheterization
- 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
Age
- Life expectancy of \< 2 years
Other
- Unwilling to provide informed consent or complete follow-up assessments
- Severe aortic, mitral or pulmonary valve regurgitation
- Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
Who the study is looking for
- 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
Age in the registry: 22 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.