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| Name | Class |
|---|---|
| Electroducer | INDUSTRY |
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The goal of this feasibility study is to evaluate the safety and efficacy of the Renal Stimulation (RNS) by Direct Wire Pacing, during Renal Denervation (RDN) procedure in patient candidate for renal denervation with the ParadiseTM System. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Stimulation | Procedure | Renal Denervation procedure as per hospital routine practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of occurrence of adverse events | safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure | Three month after procedure |
| efficacy on Systolic Blood Pressure change to be measured with a blood pressure monitor | efficacy of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure | Three month after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on Systolic Blood Pressure | Investigate the impact of the renal denervation in the Renal Nerves Stimulation induced Systolic Blood Pressure change. | Three month after procedure |
| Systolic Blood Pressure as response prediction tool |
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Inclusion Criteria:
Exclusion Criteria:
Patients who meet any of the contraindications listed in the Instructions for Use of ParadiseTM Ultrasound Renal Denervation System will be excluded:
Patient with known secondary cause of hypertension
Patient with contraindication to chronic anticoagulation therapy or heparin
Patient with Type 1 diabetes mellitus
Patient with more than one accessory renal artery
Woman currently pregnant or breastfeeding
Patient with other concomitant conditions that may adversely affect the patient or the study outcome
Patient with mental or physical inability to participate in the study
Patient under judicial protection, tutorship, or curatorship
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Feasibility study, prospective, open-label, single center, single-arm study
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Investigate whether Renal Nerves Stimulation induced Systolic Blood Pressure change before Renal Denervation could be a reliable tool to predict mid-term Renal Denervation response
| Three month after procedure |
| Systolic Blood Pressure variation as response prediction tool | Investigate whether difference in Renal Nerves Stimulation-induced Systolic Blood Pressure change before and after Renal Denervation could be a reliable tool to predict mid-term Renal Denervation | Three month after procedure |