Clareo Health | Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
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Keep this study
Lead
Gradient Denervation Technologies
Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.
Age
22–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 1 months prior treatment
You may not be if
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)
