Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Not Applicable
Completed
- Conditions
- Chronic Heart Failure
- Interventions
- Device: PRDS-001 Renal Denervation Ultrasound System
- Registration Number
- NCT04719637
- Lead Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PRDS-001 PRDS-001 Renal Denervation Ultrasound System Renal denervation
- Primary Outcome Measures
Name Time Method MIBG-cardiac(washout rate) 6 months
- Secondary Outcome Measures
Name Time Method Urinary noradrenalin concentration 6 months Peak oxygen uptake (peak VO2) assessed by CPX 6 months Ramp duration assessed by CPX 6 months Peak load assessed by CPX 6 months MIBG-renal (washout rate) 6 months Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX 6 months VE-VCO2 slope assessed by CPX 6 months MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M) 6 months Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing) 6 months Peak VO2/heart rate assessed by CPX 6 months Peak respiratory exchange ratio assessed by CPX 6 months NYHA class 6 months MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M) 6 months
Trial Locations
- Locations (1)
Osaka University Hospital
šÆšµOsaka, Japan