Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Devices - EnligHTN™ Renal Artery Ablation Catheter

Experimental: Renal Artery Ablation -


Treatment: Devices: EnligHTN™ Renal Artery Ablation Catheter
Intervention code [1] 0 0
Treatment: Devices
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
N/A
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/ct2/show/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/ct2/show/NCT01836146