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| Name | Class |
|---|---|
| Biosensors Europe SA | INDUSTRY |
| Physio-Logic Ltd. Israel | UNKNOWN |
| AmeRuss Clinical Trials LLC, USA | UNKNOWN |
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The ReDyâą System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries.
This study will be carried out to validate the safety and the efficacy of the ReDyâą Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Redyâą Renal Denervation System | Experimental | Renal Denervation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Redyâą Renal Denervation System | Device | Renal Denervation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device-related adverse events at 1-month follow-up post treatment | Incidence of device-related Adverse Events at 1-month follow-up post treatment | 1-month post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-procedural Adverse Events at 1-month follow-up post treatment | Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment | 1-month post treatment |
| Device-related Adverse Events at 3 and 6 months follow-up post treatment |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erifyli Kalloudi | Contact | +41(0)218048000 | 143 | e.kalloudi@biosensors.com |
| Norbert Clemens, MD, PhD | Contact | +491714073000 | norbert.clemens@renal-dynamics.com |
| Name | Affiliation | Role |
|---|---|---|
| Felix Mahfoud, MD | Saarland University Medical Center Homburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Onze-Lieve-Vrouwziekenhuis | Not yet recruiting | Aalst | Belgium |
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Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment
| 3 and 6 months post treatment |
| Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months | Reduction of average systolic daytime blood pressure as assessed by 24h ambulatory blood pressure monitoring at 3-month compared to baseline | 3 months post treatment |
| Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment | Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
| Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment | Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
| Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment | Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
| ZNA Middelheim Hospital | Not yet recruiting | Antwerp | Belgium |
|
| Asklepios Klinik St. Georg | Not yet recruiting | Hamburg | Germany |
|
| Saarland University Medical Center | Not yet recruiting | Homburg | Germany |
|
| Semmelweis University | Not yet recruiting | Budapest | Hungary |
|
| Galway University Hospital | Not yet recruiting | Galway | Ireland |
|
| Kaplan Medical Center | Recruiting | Rehovot | Israel |
|
| The Cardinal Stefan WyszyĆski Institute of Cardiology | Recruiting | Warsaw | Poland |
|
| Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology | Recruiting | Novosibirsk | Russia |
|
| KCS Clinical Center of Serbia | Not yet recruiting | Belgrade | Serbia |
|
| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
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