Renal Denervation in Patients with Uncontrolled Hypertension SYMPLICITY® Flex

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

. 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.

Exclusion Criteria

. 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To demonstrate that renal denervation achieved via the delivery of RF energy<br /><br>is safe, and not associated with clinically significant adverse events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To document the physiologic effects of denervation in patients with refractory<br /><br>hypertension.<br /><br>To determine whether renal denervation contributes to hypertension control.<br /><br>To determine whether renal denervation improves renal function<br /><br>To determine whether renal denervation contributes to improvement of glucose<br /><br>management in patients with abnormal baseline Hemoglobin A1c<br /><br>To assess the performance of the Ardian Symplicity Catheter System </p><br>