Heart Failure Patients With Pulmonary Hypertension
Conditions
Brief summary
Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension
Interventions
Pulmonary artery denervation (PADN) procedure
Sponsors
Gradient Denervation Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
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 * N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL * Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
Exclusion criteria
* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device * Systemic infection or localized infection/rash at planned access site at time of procedure * Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months * CRT or other Interventional cardiac procedure (except RHC) within last 3 months * Any planned cardiac procedure or inpatient procedure within the next 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device related serious adverse events | 30 days post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Pulmonary Vascular Resistance (woods units) | 6- months post-treatment |
Countries
Georgia
Outcome results
None listed