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

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