NL-OMON46439撤回不适用
Global Clinical Study of Renal Denervation with the Symplicity Spyral* multi-electrode renal denervation system in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive Medications - SPYRAL HTN-OFF MED
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Individual is * 20 and * 80 years old at time of enrollment (consent).
- •2. Individual has an office systolic blood pressure (SBP) * 150 mmHg and <180 mmHg and an office DBP *90 mmHg measured at Screening Visit 2, according to the guidelines in Appendix L.7.
- •3. Individual has a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP *140 mmHg and <170 mmHg measured at Screening Visit 2 according to guidelines in Appendix L.7.
- •4. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
- •5. Individual is willing to discontinue current antihypertensive medications at Screening Visit 1 through the three month post-procedure visit
排除标准
- •1. 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. Patients are
- •permitted to take aspirin or clopidogrel for cardiovascular risk reduction.
- •2. Individual has undergone prior renal denervation
- •3. Individual has renal artery anatomy that is ineligible for treatment including:
- •a. Presence of FMD (defined as visible beading of the artery on angiography)
- •b. Lacks a main renal arterial vessel (greater than 3mm and less than 8mm in
- •diameter) for each kidney that:
- •*. Does not allow 4 simultaneous quadrantic (4SQ) radio frequency ablations in the main renal artery or equivalent (defined as 4SQ ablations in all branch vessels greater than 3mm and less than 8mm)
- •* Has >50% stenosis
- •* Has a renal artery stent placed <3 months prior to the denervation
- •4. Treatment within 5mm of a segment in the renal artery which contains any of the following:
- •a. Atheroma,
- •b. Calcification,
- •c. Aneurysm, or
- •d. Renal artery stent
- •5. Individual has an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m2, using
- •the 4 variable MDRD calculation (in mL/min per 1.73 m2 = 175 x SerumCr-1.154 x age-0.203 x
- •1.212 (if patient is black) x 0.742 (if female). (NOTE: an eGFR calculation specific to
- •Japanese patients will be used for subjects enrolled in Japan)
- •6. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes
- •mellitus with glycosylated hemoglobin greater than 8.0% or is taking SGLT2 inhibitors or
- •GLP-1 agonists.
- •7. Individual has had *1 episode(s) of orthostatic hypotension not related to medication
- •changes within the past year or reduction of SBP of *20 mmHg or DBP of *10 mmHg within
- •3 minutes of standing coupled with symptoms during the screening process.
- •8. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal
- •respiratory support for sleep apnea (e.g. CPAP, BiPAP).
- •9. Individual is being treated chronically (e.g. daily use) with non-steroidal anti-inflammatory
- •drugs (NSAIDs). Aspirin therapy is allowed.
- •10. Individual has documented primary pulmonary hypertension.
- •11. Individual has known pheochromocytoma, Cushing*s Syndrome (hypercortisolism), primary
- •hyperaldosteronism coarctation of the aorta, untreated hyperthroidism, untreated
- •hypothyroidism, or primary hyperparathyroidism. (Note: treated hyperthyroidism and treated
- •hyperthyroidism are permissible).
- •12. Individual has a scheduled or planned surgery that, in the opinion of the Investigator, may
- •affect study endpoints.
- •13. Individual has a documented condition that would prohibit or interfere with ability to obtain
- •an accurate blood pressure measurement using the protocol-specified automatic blood
- •pressure monitor (e.g., upper arm circumference outside cuff size ranges available by
- •geography or arrhythmia that interferes with automatic monitor*s pulse sensing and
- •prohibits an accurate measurement).
- •14. Individual works night shifts.
- •15. Individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a
- •significant reduction of blood pressure is contraindicated.
- •16. Individual has a documented confounding me
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