EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension

Study Overview
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Brief Summary
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The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with drug-resistant uncontrolled hypertension.

Detailed Description
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The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. Subject randomized to the treatment group will be followed up for three years post procedure.

Official Title
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Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Device: EnligHTN Renal Denervation
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥18 years of age and ≤ 80 years of age at time of informed consent for participation in the clinical investigation 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 an office Systolic Blood Pressure ≥ 160 mmHg based on an average of 3 Blood Pressure readings at the confirmatory visit (except for subjects with Diabetes Mellitus Type II who must demonstrate an office Systolic Blood Pressure of ≥ 150 mmHg) Subject has a daytime mean Systolic 24-hour Ambulatory Blood Pressure value of ≥ 140 mmHg as measured during the two week screening period and confirmed at the confirmatory visit Subject is taking ≥ 3 antihypertensive medications concurrently at full tolerated doses (this must include one diuretic) or subject is taking a diuretic and has a documented intolerance to at least two (2) out of the three (3) remaining major classes of anti-hypertensives (ACE / ARB, Calcium Channel Blockers, Beta blockers and is unable to take 3 anti-hypertensive drugs) o Intolerance is defined as an absolute contraindication to an anti-hypertensive medication according to the approved labeling or an inability to take an anti-hypertensive medication as prescribed due to an adverse drug effect including an immune mediated response or interaction with other medications. Subjects must be on a stable antihypertensive medication regimen for a minimum of 2 weeks prior to completing the initial screening visit and the medication regimen must remain unchanged during the 2 week screening period following signing consent. Subject must be assessed at the confirmatory visit with no expected changes for at least six (6) months Exclusion Criteria: Subject has had a previous renal denervation attempt Subject has known cause of secondary hypertension other than sleep apnea Subjects with significant renovascular abnormalities such as renal artery stenosis >30%, previous renal stenting or angioplasty, renal artery occlusion, renal vein thrombosis, renal aneurysm or renal atheroembolism Subject has had a myocardial infarction, unstable angina pectoris, or cerebrovascular accident < 180 days prior to enrollment Subject has hemodynamically significant valvular heart disease as determined by a Study Investigator Subject is expected to have any cardiovascular intervention within 180 days of enrollment Subject has blood clotting abnormalities such as thrombocytopenia, hemophilia, or significant anemia Subject life expectancy is < 12 months, as determined by a Study Investigator Subject is participating in another Clinical Investigation (IND or IDE) Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods Subject has active systemic infection as determined by a Study Investigator Subject has main renal arteries with diameter(s) < 4 mm in diameter or < 20 mm in length or multiple renal arteries where the main renal arteries supply <75% of the kidney Subject has eGFR < 45 mL/min per 1.73 m2 using the MDRD formula Subject has evidence of significant AAA defined as an aneurysm size of ≥5.0 cm in width and/or involving the renal arteries, and/or requiring surgical or percutaneous intervention within 6 months of enrollment. Subject has had >1 in-patient hospitalization for a hypertensive crisis within 12 months Subject has a condition which would interfere with the accurate interpretation of the study endpoints Any condition that would prohibit or interfere with the ability to obtain accurate Blood Pressure measurements using the CIP specific automatic Blood Pressure monitor Subject has Systolic Blood Pressure values which are greater than 20mmHg apart after six (6) measurements as assessed at the confirmatory visit

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Renal artery ablation with the EnligHTN™ Renal Denervation System. | Device: EnligHTN Renal Denervation<br>* Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system<br>|
| Active Comparator: Sham procedure<br>Sham procedure | Procedure: Sham<br>* Renal artery angiogram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC). | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred. | 6 months post randomization | 
| The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups |  | 6 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. | 6 months post randomization | 
| The Number of Subjects That Experience Each Type of MAE | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. | 6 months post randomization | 
| Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. | 6 months post randomization, and all follow-up timepoints | 
| Reduction in Ambulatory Blood Pressure (ABP) Parameters | The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis. | baseline, 6 months post randomization, and all follow-up timepoints | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, resistant hypertension, renal denervation