Observational Study of the EnligHTN Renal Denervation System in Europe

Study Overview
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Brief Summary
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The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.

Detailed Description
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The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.

Official Title
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EnligHTN European Observational Study

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Device: EnligHTN™ Renal Denervation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is planned to undergo a renal denervation procedure for the treatment of hypertension Subject is ≥18 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 SBP ≥ 140 mmHg Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic) Exclusion Criteria: Subject has known significant renovascular abnormalities such as renal artery stenosis > 30% Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts Subject has a history of hemodynamically significant valvular heart disease Subject has blood clotting abnormalities Subject life expectancy is < 12 months, as determined by the Study Investigator Subject is participating in another clinical study which has the potential to impact his/her 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 known renal arteries with diameter(s) < 4 mm Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula Subject had a renal transplant or is awaiting a renal transplant

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uncontrolled hypertension patients<br>The study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension. | Device: EnligHTN™ Renal Denervation System<br>* The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Office Systolic Blood Pressure at 6 Months |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure |  | 30 days | 
| Mean Change in Office Systolic Blood Pressure at 1 Month |  | Baseline and 1 month | 
| Mean Change in Office Diastolic Blood Pressure at 1 Month |  | Baseline and 1 month | 
| Mean Change in Ambulatory Systolic Blood Pressure at 1 Month |  | Baseline and 1 month | 
| Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month |  | Baseline and 1 month | 
| Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month |  | 1 month | 
| Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months |  | Baseline and 6 months | 
| Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months |  | Baseline and 12 months | 
| Renovascular Safety at 6 Months (Renal Artery Stenosis) | Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation. | 6 months | 
| Mean Change in Office Systolic Blood Pressure at 12 Months |  | Baseline and 12 months | 
| Mean Change in Office Diastolic Blood Pressure at 6 Months |  | Baseline and 6 months | 
| Mean Change in Office Diastolic Blood Pressure at 12 Months |  | Baseline and 12 months | 
| Mean Change in Ambulatory Systolic Blood Pressure at 6 Months |  | Baseline and 6 months | 
| Mean Change in Ambulatory Systolic Blood Pressure at 12 Months |  | Baseline and 12 months | 
| Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months |  | Baseline and 6 months | 
| Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months |  | Baseline and 12 months | 
| Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months |  | 6 months | 
| Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months |  | 12 months |