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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Scientific title
Ablation-induced Renal Sympathetic Denervation Trial
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Study type
Description of intervention(s) / exposure
Treatment: Devices - St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

Experimental: renal artery ablation - Catheter-based RF ablation in renal artery

Treatment: Devices: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Catheter-based RF ablation in renal artery

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Adverse Events - All device or procedure related adverse events
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Office Systolic Blood Pressure Change
Timepoint [2] 0 0
Baseline to 6 months

Key inclusion criteria
- Office systolic blood pressure that remains =160 mmHg (=150 mmHg for patient with type
2 diabetes) despite the stable use of =3 antihypertensive medications concurrently at
maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior
to enrollment

- Age =18 and =80 years old

- Able and willing to provide written informed consent to participate in the study

- Able and willing to comply with the required follow-up schedule
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Prior renal artery intervention (balloon angioplasty or stenting)

- Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in
either renal artery

- Multiple main renal arteries in either kidney

- Main renal arteries <4 mm in diameter or <20 mm in length

- eGFR of <45 mL/min per 1.73 m2 using the MDRD formula

- Type 1 diabetes

- Renovascular hypertension or hypertension secondary to other renal disorders
(glomerulonephritis, polycystic kidney disease, end-stage renal failure)

- Others

Study design
Purpose of the study
Allocation to intervention
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Abbott Medical Devices

Ethics approval
Ethics application status

Brief summary
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal
denervation in patients with resistant hypertension.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Vasilias Papademetriou, MD
Address 0 0
First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece
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
Other publications