This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Northwestern University
Chicago, Illinois, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDuke University
Durham, North Carolina, United States
Device related serious adverse events
Frequency of SAEs deemed to be related to the investigational device and/or procedure.
Time frame: Through 30 days post-treatment
Mean change from baseline in Pulmonary Vascular Resistance (woods units)
Calculated mean percent change from baseline
Time frame: Measured at 6 months post-treatment
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Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGHouston Methodist
Houston, Texas, United States
RECRUITINGUniversity of Wisconsin
Madison, Wisconsin, United States
RECRUITINGAurora Health
Milwaukee, Wisconsin, United States
RECRUITING