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



Status:Terminated
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:2/17/2019
Start Date:October 2013
End Date:November 2016

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

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.

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
We found this trial at
3
sites
Jackson, Mississippi 39216
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Jackson, MS
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Huntsville, Alabama 35801
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Huntsville, AL
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Little Rock, Arkansas 72211
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Little Rock, AR
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