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International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension | Clinical Trials | Clareo Health

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International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension

NCT01836146•Abbott Medical Devices

View on ClinicalTrials.gov

Summary

The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is ≥ 18 and ≤ 80 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 ≥ 160 mmHg at confirmatory visit
•Subject has a daytime mean Systolic Ambulatory Blood Pressure \> 135 mmHg during the two week screening period
•Subject has an office Systolic Blood Pressure that remains ≥160 mmHg despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic or subject was previously on diuretic but documented to be diuretic intolerant, for a minimum of 14 days prior to the procedure and with an expectation to maintain for a minimum of 180 days post procedure.

Exclusion Criteria

•Subject has significant renovascular abnormalities such as renal artery stenosis \> 30% in either renal artery
•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 the Study Investigator
•Subject has a life expectancy less than 12 months, as determined by a Study 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 or \<20 mm in length
•Subject has an estimated Glomerular Filtrate Rate (eGFR) \<45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
•Subject has Diabetes Mellitus Type I
+6 more criteria

Locations (6)

St Andrews Hospital

Adelaide, South Australia, Australia

St. Vincent's Hospital Melbourne

Fizroy, Victoria, Australia

Monash Heart/Southern Health

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Auckland City Hospital

Auckland, New Zealand

Dunedin Hospital

Dunedin, New Zealand

Key Dates

Start Date

April 1, 2013

Primary Completion Date

March 1, 2014

Completion Date

September 1, 2015

Last Updated

February 4, 2019

Enrollment

ACTUAL participants

Conditions

HypertensionRenal Denervation

Interventions

EnligHTN™ Renal Artery Ablation Catheter

DEVICE

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension

Inclusion Criteria

Exclusion Criteria

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