Renal Denervation in Patients with Uncontrolled Hypertension SYMPLICITY® Flex - Renal Denervation

Ardian, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•. Individual has a systolic blood pressure higher than 160 mmHg (higher than 150 mmHg for type 2 diabetics). 2. Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment) that is expected to be maintained for at least 6 months. 3. Individual is >=18 and <= 85 years of age.

•. Individual has anatomically abnormal renal artery (this is defined in detail in the study protocol on page 13). 2. Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2 3. Individual has type 1 diabetes mellitus. 4. Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months from the screening visit, or has widespread atherosclerosis. 5. Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months. 6. Individual has hemodynamically significant valvular heart disease. 7. Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with MRI. 8. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study. 9. Individual is pregnant, nursing or planning to be pregnant. 10. Individual has a known, unresolved history of drug use or alcohol dependency. 11. Individual is currently enrolled in another investigational drug or device trial.

发起方

Ardian, Inc.