International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension

Study Overview
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Brief Summary
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The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.

Conditions
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Hypertension, Renal Denervation

Intervention / Treatment
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* Device: EnligHTN™ Renal Artery Ablation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 and ≤ 80 years of age at time of consent Subject must be able and willing to provide written informed consent Subject must be able and willing to comply with the required follow-up schedule Subject has office Systolic Blood Pressure ≥ 160 mmHg at confirmatory visit Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg during the two week screening period Subject has an office Systolic Blood Pressure that remains ≥160 mmHg despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic or subject was previously on diuretic but documented to be diuretic intolerant, for a minimum of 14 days prior to the procedure and with an expectation to maintain for a minimum of 180 days post procedure. Exclusion Criteria: Subject has significant renovascular abnormalities such as renal artery stenosis > 30% in either renal artery Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts Subject has hemodynamically significant valvular heart disease as determined by the Study Investigator Subject has a life expectancy less than 12 months, as determined by a Study Investigator Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic) Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods Subject has active systemic infection Subject has renal arteries with diameter(s) < 4 mm in diameter or <20 mm in length Subject has an estimated Glomerular Filtrate Rate (eGFR) <45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula Subject has Diabetes Mellitus Type I Subject has multiple main renal arteries in either kidney Subject has an identified secondary cause of hypertension (for example, including, but not limited to, Polycystic kidney disease, Cushing's syndrome, Aldosteronism) Subject has evidence of significant abdominal aortic aneurysm (defined as maximum diameter of >4 cm) Subject has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days prior to enrollment Subject is expected to have cardiovascular intervention within the next 180 days Subject has a condition which would interfere with the accurate interpretation of the study objectives including but not limited to a large arm diameter that is unable to accommodate the blood pressure cuff or arrhythmia that interferes with automatic pulse sensing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Artery Ablation<br> | Device: EnligHTN™ Renal Artery Ablation Catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Objective | To characterize the rate of serious procedural and device related adverse events from date of procedure through 6 months post procedure, as adjudicated by the Clinical Events Committee (CEC). | 6 months | 
| Performance objective | To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ambulatory Blood Pressure | Characterization of the change in Ambulatory Blood Pressure parameters over time as compared to baseline | 1 month, 3 month, 6 month, 12 month, 18 month, 2 years | 
| New renal artery stenosis or aneurysm at the site of ablation | Characterization of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation over time as compared to baseline | 1 month, 3 month, 6 month, 12 month, 18 month, 2 years | 
| Renal Function Change | Characterization of renal function change over time as compared to baseline as measured by changes in: eGFR, serum creatinine and cystatin C | 1 month, 3 month, 6 month, 12 month, 18 month, 2 years |