Status:
TERMINATED
EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension
Lead Sponsor:
Abbott Medical Devices
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 uncontro...
Detailed Description
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 grou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01903187
Start Date
October 1 2013
End Date
November 1 2016
Last Update
February 15 2019
Active Locations (3)
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1
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
2
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
3
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216