Pulmonary artery denervation for heart failure patients with pulmonary hypertension
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
This study is testing a new treatment to see if it can help heart failure patients with high blood pressure in their lungs feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 22 Years to 85 Years |
| Sex | All |
| Sponsor | Gradient Denervation Technologies Industry-sponsored |
| Locations | 8 sites (Chicago, Illinois and 7 other locations) |
| Trial ID | NCT06052072 on ClinicalTrials.gov |
What this trial studies
This early feasibility study aims to evaluate the effects of a novel pulmonary artery denervation system on the quality of life for heart failure patients suffering from Group 2 pulmonary hypertension. The study focuses on patients who have heart failure with preserved ejection fraction and elevated pulmonary artery pressures. By targeting pulmonary hypertension, the intervention seeks to improve exercise capacity and overall quality of life in this patient population, which currently lacks effective treatment options for their condition.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients with an ejection fraction of 40% or greater and specific pulmonary artery pressure measurements.
Not a fit: Patients with a life expectancy of less than one year or those unable to tolerate necessary medical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and exercise capacity for heart failure patients with pulmonary hypertension.
How similar studies have performed: While this approach is novel, similar studies targeting pulmonary hypertension in heart failure patients have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Heart Failure with EF ≥ 40% (by TTE within last 3 months) * 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 * Cardiac index (CI) ≥ 1.7 L/min/m2 * NYHA Class II or III * Glomerular Filtration Rate (GFR) ≥ 25 ml/min * Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment Exclusion Criteria: * Ambulatory with a Life expectancy of \< 1 years * Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * Unable to tolerate right heart catheterization * Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device * Severe aortic, mitral or pulmonary valve regurgitation * Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy * Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
Where this trial is running
Chicago, Illinois and 7 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- Houston Methodist — Houston, Texas, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
- Aurora Health — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Jason McCarthy
- Email: clinical@gradientdenervation.com
- Phone: 763-657-7036
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.