IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (EnligHTN-II)

Abbott

Status: Terminated

Conditions: Hypertension; Blood Pressure

Treatments: Device: EnligHTN

Study type: Observational

Funder types: Industry

Identifiers

NCT01705080

1201

Details and patient eligibility

About

The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

Full description

This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five years post procedure.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is ≥ 18 years of age at time of consent
• 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 office Systolic Blood Pressure ≥ 140 mmHg at confirmatory visit
• Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
• Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is on a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3 anti-hypertensive medications (including 1 diuretic) or subject has a documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.

Exclusion criteria

• Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
• Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
• Subject has hemodynamically significant valvular heart disease as determined by study investigator
• Subject has a life expectancy less than 12 months, as determined by the Investigator
• Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
• Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
• Subject has active systemic infection
• Subject has renal arteries with diameter(s) < 4 mm in diameter
• Subject has an estimated GFR <15 mL/min per 1.73 m^2 using the MDRD formula
• Subject had a renal transplant or is awaiting a renal transplant
• Subject has blood clotting abnormalities

Trial design

276 participants in 3 patient groups

A - EnligHTN for Severe Resistant HTN

Description:

* Office systolic Blood Pressure ≥160 mmHg * Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Patient has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula

Treatment:

Device: EnligHTN

B - EnligHTN for Resistant HTN

Description:

* Office systolic Blood Pressure ≥140 mmHg * Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Patient has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula

Treatment:

Device: EnligHTN

C - EnligHTN for Resistant HTN & CKD

Description:

* Office systolic Blood Pressure ≥140 mmHg * Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Patient has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula

Treatment:

Device: EnligHTN