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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01836146




Registration number
NCT01836146
Ethics application status
Date submitted
16/04/2013
Date registered
19/04/2013
Date last updated
4/02/2019

Titles & IDs
Public title
International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
Scientific title
Secondary ID [1] 0 0
1202
Universal Trial Number (UTN)
Trial acronym
EnligHTN III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Renal Denervation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Renal Artery Ablation -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Objective
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Performance objective
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Change in Ambulatory Blood Pressure
Timepoint [1] 0 0
1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Secondary outcome [2] 0 0
New renal artery stenosis or aneurysm at the site of ablation
Timepoint [2] 0 0
1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Secondary outcome [3] 0 0
Renal Function Change
Timepoint [3] 0 0
1 month, 3 month, 6 month, 12 month, 18 month, 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
* Subject has multiple main renal arteries in either kidney
* Subject has an identified secondary cause of hypertension (for example, including, but not limited to, Polycystic kidney disease, Cushing's syndrome, Aldosteronism)
* Subject has evidence of significant abdominal aortic aneurysm (defined as maximum diameter of >4 cm)
* Subject has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days prior to enrollment
* Subject is expected to have cardiovascular intervention within the next 180 days
* Subject has a condition which would interfere with the accurate interpretation of the study objectives including but not limited to a large arm diameter that is unable to accommodate the blood pressure cuff or arrhythmia that interferes with automatic pulse sensing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
St Andrews Hospital - Adelaide
Recruitment hospital [2] 0 0
St. Vincent's Hospital Melbourne - Fizroy
Recruitment hospital [3] 0 0
Monash Heart/Southern Health - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Fizroy
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01836146
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01836146