IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

Abbott Medical Devices33 sites in 11 countries276 target enrollmentJanuary 17, 2013

ConditionsHypertension Blood Pressure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hypertension
Sponsor: Abbott Medical Devices
Enrollment: 276
Locations: 33
Primary Endpoint: Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

January 17, 2013

End Date

November 27, 2019

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months

Time Frame: Baseline to 6 months

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Secondary Outcomes

Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure(30 days post procedure)
Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months(6 months)
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months(Confirmatory visit to 6 months)
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years(2 years)
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years(5 years)
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years(Confirmatory visit to 2 years)
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years(Confirmatory visit to 5 years)
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months(Baseline to 6 months)
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months(Baseline to 6 months)
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months(Baseline to 6 months)
Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months(6 months)
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation(Baseline to 1 year)
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation(Baseline to 2 years)
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation(Baseline to 3 years)
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation(Baseline to 4 years)
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation(Baseline to 5 years)
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation(Baseline to 1 year)
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation(Baseline to 2 years)
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation(Baseline to 3 years)
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation(Baseline to 4 years)
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation(Baseline to 5 years)
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation(Baseline to 1 year)
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation(Baseline to 2 years)
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation(Baseline to 3 years)
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation(Baseline to 4 years)
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation(Baseline to 5 years)
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation(Baseline to 1 year)
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation(Baseline to 2 years)
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation(Baseline to 3 years)
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation(Baseline to 4 years)
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation(Baseline to 5 years)