enlightn iv trial - multicenter sham-controlled rct of renal denervation for hypertension

Conditions: Hypertension

Summary: 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.

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.

Eligibility criteria:
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

Keywords: hypertension resistant hypertension renal denervation