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The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to include up to one hundred (100) eligible patients as defined within the clinical investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous renal denervation | Experimental | PARADISE percutaneous renal denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARADISE percutaneous renal denervation | Device | Intravascular ultrasound emission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with device- or procedure-related adverse events | Anticipated adverse events include:
| 12 months |
| Change from baseline in systolic blood pressure | Change from baseline in systolic blood pressure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in diastolic blood pressure | Change from baseline in diastolic blood pressure | 12 months |
| Change from baseline in anti-hypertensive medication intake | Change from baseline in anti-hypertensive medication intake |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in EQ-5D Quality of Life score | Change from baseline in EQ-5D Quality of Life score | 12 months |
| Change from baseline in cardiac function | Change from baseline in cardiac function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Zeller, Professor | Universitäts-Herzzentrum Freiburg • Bad Krozingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Herzzentrum Freiburg • Bad Krozingen | Bad Krozingen | 79189 | Germany | |||
| Universitätsklinikum Essen |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 12 months |
| Changes from baseline in pulse pressure and nocturnal dipping | Changes from baseline in pulse pressure and nocturnal dipping | 12 months |
| 12 months |
| Essen |
| 45147 |
| Germany |
| CardioVasculäres Centrum | Frankfurt | 60389 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66424 | Germany |
| Universitätsklinikum Lübeck | Lübeck | 23538 | Germany |
| Erasmus MC - Thoraxcenter | Rotterdam | 3015 | Netherlands |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |