The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Renal Denervation Ultrasound System
Osaka University Hospital
Osaka, Japan
MIBG-cardiac(washout rate)
Time frame: 6 months
MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M)
Time frame: 6 months
Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing)
Time frame: 6 months
Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX
Time frame: 6 months
Peak oxygen uptake (peak VO2) assessed by CPX
Time frame: 6 months
Peak VO2/heart rate assessed by CPX
Time frame: 6 months
VE-VCO2 slope assessed by CPX
Time frame: 6 months
Peak respiratory exchange ratio assessed by CPX
Time frame: 6 months
Peak load assessed by CPX
Time frame: 6 months
Ramp duration assessed by CPX
Time frame: 6 months
Urinary noradrenalin concentration
Time frame: 6 months
NYHA class
Time frame: 6 months
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MIBG-renal (washout rate)
Time frame: 6 months
MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M)
Time frame: 6 months