Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
Not Applicable
Active, not recruiting
- Conditions
- Heart Failure Patients With Pulmonary Hypertension
- Interventions
- Device: Gradient Denervation System
- Registration Number
- NCT05951166
- Lead Sponsor
- Gradient Denervation Technologies
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PADN with Gradient Denervation System Gradient Denervation System -
- Primary Outcome Measures
Name Time Method Device related serious adverse events 30 days post-treatment
- Secondary Outcome Measures
Name Time Method Mean change from baseline in Pulmonary Vascular Resistance (woods units) 6- months post-treatment
Trial Locations
- Locations (2)
Israeli-Georgian Medical Research Clinic Helsicore
🇬🇪Tbilisi, Georgia
Tbilisi Heart Clinic
🇬🇪Tbilisi, Georgia