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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRDS-001 | Experimental | Renal denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRDS-001 Renal Denervation Ultrasound System | Device | Renal Denervation Ultrasound System |
|
| Measure | Description | Time Frame |
|---|---|---|
| MIBG-cardiac(washout rate) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M) | 6 months | |
| Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing) | 6 months | |
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Inclusion Criteria :
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka University Hospital | Osaka | Japan |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX |
| 6 months |
| Peak oxygen uptake (peak VO2) assessed by CPX | 6 months |
| Peak VO2/heart rate assessed by CPX | 6 months |
| VE-VCO2 slope assessed by CPX | 6 months |
| Peak respiratory exchange ratio assessed by CPX | 6 months |
| Peak load assessed by CPX | 6 months |
| Ramp duration assessed by CPX | 6 months |
| Urinary noradrenalin concentration | 6 months |
| NYHA class | 6 months |
| MIBG-renal (washout rate) | 6 months |
| MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M) | 6 months |