NL-OMON51861招募中不适用
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM) - SPYRAL AFFIRM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
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 >=18 years of age at time of enrollment (consent)
- •2) Individual is diagnosed with hypertension and has an average baseline office
- •systolic blood pressure >=140 mmHg (measured per Appendix B)
- •3) >=7 days of valid pre-procedure HBP measurements within 30 days prior to the
- •procedure; consecutive days are preferred but not required (measured per
- •Section 9.5) Not applicable for the Continuation Cohort
- •4) Individual agrees to have all study procedures performed and is competent
- •and willing to provide documented informed consent to participate in this
- •clinical study. Continuation Cohort must again meet this criterion at time of
- •SPYRAL AFFIRM Consent
- •5) Individual was initially randomized to the treatment arm and successfully
- •underwent the RDN procedure, in either the SPYRAL-PIVOTAL- SPYRAL -HTN-OFF MED
- •or SPYRAL HTN-ON MED study. Continuation Cohort only
- •6) Individual has completed their 36- month visit and been exited from the
- •SPYRAL-PIVOTAL- SPYRAL-HTN OFF MED or SPYRAL HTN-ON MED study. Continuation
- •Cohort only
- •7) Individual has a baseline office diastolic blood pressure >=90 mmHg (measured
- •per Appendix B)
- •8) Individual has an average systolic baseline home blood pressure >=135 mmHg
- •(calculated using home blood pressure readings from the first 7 valid days
- •post-baseline).
排除标准
- •1) Individual has renal artery anatomy that is ineligible for treatment
- •a) At least one main renal artery with a diameter of less than 3 mm or greater
- •b) Lacks a main renal arterial vessel 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 between 3mm and 8mm)
- •2) Individual has >50% stenosis in any treatable vessels.
- •3) Individual has a treatment area within 5mm of a segment in the renal artery
- •which contains any of the following:
- •a) Atheroma
- •b) Calcification, or
- •c) Renal artery stent
- •4) Individual has a renal artery stent placed <3 months prior to procedure
- •5) Individual has undergone prior renal denervation
- •6) Presence of fibromuscular dysplasia (FMD) (defined as visible beading of the
- •artery on angiography)
- •7) Individual has untreated secondary cause of hypertension (either known or
- •suspected). Secondary cause does not include obstructive sleep apnea
- •8) Individual has a documented condition that would prohibit or interfere with
- •ability to obtain an accurate blood pressure measurement using the
- •protocol-specified blood pressure monitors (e.g., upper arm circumference
- •outside cuff size ranges or arrhythmia that interferes with monitor*s pulse
- •sensing or prohibits an accurate measurement) Continuation Cohort must not meet
- •this criterion again at time of SPYRAL AFFIRM Consent.
- •9) Individual has a documented confounding medical condition, which in the
- •opinion of the investigator, may adversely affect the safety of the participant
- •(e.g., individuals with clinically significant peripheral vascular disease, or
- •aortic aneurysm)
- •10) Individual requires chronic oxygen support or mechanical ventilation other
- •than nocturnal respiratory support for sleep apnea (e.g. CPAP, BiPAP)
- •11) Individual has an estimated glomerular filtration rate (eGFR) of <45
- •mL/min/1.73m2, using the 4 variable MDRD calculation (in mL/min per 1.73m2 =
- •175 x SerumCr -1.154 x Age -0.203 x 1.212 (if subject is of African descent) x
- •0.742 (if subject is female).
- •12) Individual has had >= 1 episode(s) of orthostatic hypotension not related to
- •medication changes within the past year or has a reduction of SBP of >= 20 mmHg
- •or DBP of >=10 mmHg within 3 minutes of standing coupled with symptoms during
- •the screening process
- •13) Individual is pregnant, nursing or planning to become pregnant during the
- •study. (Note: Pre-menopausal participants must have a negative serum or urine
- •human chorionic gonadotropin (hCG) pregnancy test prior to angiography)
- •Continuation Cohort must not meet this criterion again at time of SPYRAL AFFIRM
- •14) Individual has polycystic kidney disease, unilateral kidney, atrophic
- •kidney, or history of renal transplant
- •15) Individual has a history of narcotic drug abuse or is currently on
- •Methadone, and would be unlikely or unable, in the opinion of the investigator,
- •to comply with study follow-up requirements
- •16) Individual has a history of bleeding diathesis (bleeding disorders such as
- •thrombocytopenia, hemophilia, significant anemia, or evidence of autonomic
- •dysfunction where imbalance of sympathetic and parasympathetic tone may alter
- •disease process in an unpredictable manner) or coagulopathy or will refuse
- 另有 1 项未显示
研究者
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