Pulmonary Hypertension
Conditions
Brief summary
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Detailed description
The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.
Interventions
The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.
Sponsors
Gradient Denervation Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 * NYHA Class II or III * Glomerular Filtration Rate (GFR) ≥ 25 ml/min
Exclusion criteria
* Unwilling to provide informed consent or complete follow-up assessments * Life expectancy of \< 2 years * Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * Unable to tolerate right heart catheterization * Severe aortic, mitral or pulmonary valve regurgitation * Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery) * Systemic infection or localized infection/rash at planned access site at time of procedure * CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device related serious adverse events | 30-days post-treatment | Frequency of device related SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in Pulmonary Vascular Resistance (woods units) | 6 month post-treatment | Calculated percent mean change from baseline |
Countries
Spain
Contacts
Primary ContactJulie Etheridge
Outcome results
None listed