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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01699529




Registration number
NCT01699529
Ethics application status
Date submitted
21/09/2012
Date registered
3/10/2012
Date last updated
26/10/2016

Titles & IDs
Public title
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Scientific title
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Secondary ID [1] 0 0
10058715DOC
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

Experimental: Renal Denervation -


Treatment: Devices: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute safety as measured by procedural complications
Timepoint [1] 0 0
1 month
Secondary outcome [1] 0 0
Change in Office Systolic Blood Pressure
Timepoint [1] 0 0
Baseline to 6 months

Eligibility
Key inclusion criteria
* Individual is = 18 and = 80 years old.
* Individual has an office systolic blood pressure of 160 mmHG or greater (= 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
* Individual is adhering to a stable medication regimen including = 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
* Individual has type 1 diabetes mellitus
* Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to be pregnant.

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
1/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [3] 0 0
Epworth Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
Recruitment postcode(s) [3] 0 0
3069 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.
Trial website
https://clinicaltrials.gov/study/NCT01699529
Trial related presentations / publications
Whitbourn R, Harding SA, Walton A. Symplicity multi-electrode radiofrequency renal denervation system feasibility study. EuroIntervention. 2015 May;11(1):104-9. doi: 10.4244/EIJV11I1A18.
Public notes

Contacts
Principal investigator
Name 0 0
Robert Whitbourn, MD
Address 0 0
St Vincent's Hospital Melbourne
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/NCT01699529