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Trial details imported from

For full trial details, please see the original record at

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

Titles & IDs
Public title
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
Scientific title
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Study type
Description of intervention(s) / exposure
Treatment: Surgery - Renal Denervation

Other: Single arm - Renal Denervation

Treatment: Surgery: Renal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population

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

Primary outcome [1] 0 0
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Timepoint [1] 0 0
6 month
Secondary outcome [1] 0 0
Ventricular function as measured by Echocardiography
Timepoint [1] 0 0
6 month
Secondary outcome [2] 0 0
Renal function as measured by Glomerular Filtration Rate (GFR)
Timepoint [2] 0 0
6 months

Key inclusion criteria
- Heart Failure patients NYHA Class II or III

- Renal Impairment Left Ventricular Ejection Function <40%

- GFR 30 to 75 mL/min/1.73m2

- Optimal stable medical therapy
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Renal artery anatomy must be eligible for treatment as determined by Angiography, and

- History of prior renal artery intervention

- Single functioning kidney.

- Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3

- Systolic BP < 90 mmHG

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
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Medtronic Vascular

Ethics approval
Ethics application status

Brief summary
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary
aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe
and determine the evidence of a response to renal denervation in patients with Heart Failure.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Henry Krum, MD
Address 0 0
The Alfred
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