Using ultrasound to treat pulmonary hypertension in heart failure patients
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
This study tests whether using ultrasound to treat pulmonary hypertension can help heart failure patients feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 22 Years to 85 Years |
| Sex | All |
| Sponsor | Gradient Denervation Technologies Industry-sponsored |
| Locations | 3 sites (Badalona and 2 other locations) |
| Trial ID | NCT06495970 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Gradient Denervation System, which utilizes ultrasound ablation to reduce sympathetic nervous activity in the pulmonary artery. The goal is to improve the quality of life for heart failure patients suffering from Group 2 pulmonary hypertension. Participants will undergo a procedure where a catheter is used to deliver targeted ultrasound energy to specific locations in the pulmonary artery. The study aims to assess changes in pulmonary artery pressure and overall patient well-being following the intervention.
Who should consider this trial
Good fit: Ideal candidates are heart failure patients with Group 2 pulmonary hypertension, specifically those with elevated pulmonary artery pressure and certain functional limitations.
Not a fit: Patients with severe valve regurgitation or those unable to tolerate the required procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for patients with pulmonary hypertension and heart failure.
How similar studies have performed: While the approach of using ultrasound ablation for pulmonary artery denervation is innovative, similar studies have shown promise in related areas, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Badalona and 2 other locations
- Hospital Universitari Germans Trias i Pujol — Badalona, Spain (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Julie Etheridge
- Email: clinical@gradientdenervation.com
- Phone: +49 16094434355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.