Overview

This trial is active, not recruiting.

Conditions hypertension, blood pressure
Treatment enlightn
Sponsor St. Jude Medical
Start date January 2013
End date February 2017
Trial size 354 participants
Trial identifier NCT01705080, 1201

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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 m2 using the Modification of Diet in Renal Disease (MDRD) formula
enlightn
Renal artery ablation with EnligHTN system used for all groups
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 m2 using the Modification of Diet in Renal Disease (MDRD) formula
enlightn
Renal artery ablation with EnligHTN system used for all groups
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 m2 using the Modification of Diet in Renal Disease (MDRD) formula
enlightn
Renal artery ablation with EnligHTN system used for all groups

Primary Outcomes

Measure
• Mean reduction in office Systolic Blood Pressure at six (6) months across all subjects post renal denervation and within sub-groups
time frame: 6 months post procedure

Secondary Outcomes

Measure
Percent of patients who experience a procedural related event
time frame: 30 days post procedure
Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation
time frame: 6 months, 2 years, and 5 years post procedure
Renal function change based on eGFR
time frame: 6 months, 2 years, and 5 years post procedure
Change in Ambulatory Blood Pressure parameters at 6 months
time frame: 6 months post procedure
Change in office Diastolic Blood Pressure at 6 months
time frame: 6 months post procedure
Percentage of subjects achieving office Systolic Blood Pressure < 140 at 6 month visit
time frame: 6 months post procedure
Change in Office Blood Pressure parameters at 12, 24, 36, 48, 60 months post denervation
time frame: 12, 24, 36, 48, 60 months post procedure
Change in Ambulatory Blood Pressure parameters at 12, 24, 36, 48, 60 months post denervation
time frame: 12, 24, 36, 48, 60 months post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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 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 m2 using the Modification of Diet in Renal Disease (MDRD) formula - Subject had a renal transplant or is awaiting a renal transplant - Subject has blood clotting abnormalities

Additional Information

Official title IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
Principal investigator Melvin Lobo, MD
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 (5) years post procedure.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.