Hypertension
Conditions
Interventions
Renal Denervation (Renal Denervation, Renal angiography) After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation pr
Sponsors
Medtronic Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individual has office systolic blood pressure (SBP) >= 150 mmHg and < 180 mmHg and a diastolic blood pressure (DBP) >= 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes. 2. Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP >= 140 mmHg and < 170 mmHg.
Exclusion criteria
Exclusion criteria: 1. Individual has renal artery anatomy that is ineligible for treatment. 2. Individual has estimated glomerular filtration rate (eGFR) of <45. 3. Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus. 4. Individual has one or more episodes of orthostatic hypotension. 5. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. 6. Individual has primary pulmonary hypertension. 7. Individual is pregnant, nursing or planning to become pregnant. 8. Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment 9. Individual has one or more of the following conditions: stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time. Patients who received catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded. 10. Individual works night shifts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Incidence of Major Adverse Events through one-month post -procedure (6 months for new renal artery stenosis) 2.Change in systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 6 months post-procedure ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: -Change in systolic blood pressure (SBP) from baseline (Screening Visit 2) as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3, 6, 12, 24 and 36 months post-procedure -Change in office systolic blood pressure from baseline (Screening Visit 2) at 1, 3, 6, 12, 24 and 36 months post-procedure -Change in diastolic blood pressure from baseline (Screening Visit 2) as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3, 6, 12, 24 and 36 months post-procedure -Change in office diastolic blood pressure from baseline (Screening Visit 2) at 1, 3, 6, 12, 24 and 36 months post-procedure -Incidence of achieving target office systolic blood pressure at 1, 3, 6, 12, 24 and 36 months post-procedure. Safety: -Acute/procedural safety at 1-month post-procedure -Chronic Safety Secondary Endpoints at 3, 6, 12, 24 and 36 months post-procedure -Summary of Health-related Quality of Life (HRQoL) analysis based on reporting measures using accepted QoL instruments (EQ5D) | — |
Countries
Japan,North America,Australia,Europe
Contacts
Public ContactHitomi Yoshida
Medtronic Japan Co., Ltd. Japan Clinical Medical Affairs
Outcome results
None listed