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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01756300




Registration number
NCT01756300
Ethics application status
Date submitted
20/12/2012
Date registered
25/12/2012
Date last updated
11/11/2015

Titles & IDs
Public title
RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension
Scientific title
A Prospective, Multi-Center, Non-Randomized Feasibility Study of Catheter-Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)
Secondary ID [1] 0 0
RENABLATE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Renal 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Celsius® ThermoCool® RD

Experimental: Resistant Hypertension - The catheter-based (device: Celsius® ThermoCool® RD) renal denervation will serve to treat resistant hypertension.


Treatment: Devices: Celsius® ThermoCool® RD
The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.
Timepoint [1] 0 0
30 days post-procedure
Secondary outcome [1] 0 0
Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure
Timepoint [1] 0 0
12 months post-procedure
Secondary outcome [2] 0 0
Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
Timepoint [2] 0 0
From baseline to 1 ,3, 6 and 12 months post procedure
Secondary outcome [3] 0 0
Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure
Timepoint [3] 0 0
From baseline to 3, 6 and 12 months post procedure
Secondary outcome [4] 0 0
Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure
Timepoint [4] 0 0
At 1, 3, 6, and 12 month post-procedure
Secondary outcome [5] 0 0
Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure
Timepoint [5] 0 0
At 1, 3, 6, and 12 month post-procedure

Eligibility
Key inclusion criteria
1. Subject is > 18 and < 85 years old.

2. Individual has a systolic blood pressure = 160 mmHg (= 150 mmHg for type 2 diabetics)
based on an average of 3 office blood pressure readings.

3. Individual is adhering to a stable drug regimen of at least 3 different classes of
anti-hypertensive medications, including a diuretic (with no changes for a minimum of
2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at
least 6 months.

4. Individual agrees to have all study procedures performed, and is competent and willing
to provide written, informed consent to participate in this study.
Minimum age
19 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with known/diagnosed secondary hypertension.

2. Subject has 'White Coat' hypertension defined as 24 hour daytime systolic blood
pressure <135 mm Hg as evaluated at Baseline visit.

3. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the
investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter.

4. Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.

5. Subject has multiple main renal arteries in either kidney.

6. Subject has a history of prior renal artery intervention including balloon
angioplasty, stenting or surgery.

7. Subject had a previous kidney transplant or is a planned recipient of a transplant
kidney or is on dialysis.

8. Subject has a past history of unilateral kidney removal or has a solitary functional
kidney for any other reason.

9. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using
the MDRD formula.

10. Subject has type 1 diabetes mellitus.

11. Subject has history of Myocardial Infarction, unstable angina pectoris, or a
cerebrovascular accident in the 6 months period prior to enrolment, or documented
widespread atherosclerosis, intravascular thrombosis or unstable plaques.

12. Subject had a significant surgery or cardiovascular intervention in the 6 months
period preceding enrollment or is planned to have such a surgery or cardiac
intervention in the 6 months period post enrollment.

13. Subject has hemodynamically significant valvular heart disease for which reduction of
blood pressure would be considered hazardous.

14. Subject is taking systemic steroids or chronic daily NSAIDs.

15. Subject has a known allergy to Aspirin and/or other procedural drugs or contrast
agents which in the investigator's opinion excludes him/her from the study.

16. Subject has a serious medical condition, which in the opinion of the investigator, may
adversely affect the safety and/or effectiveness of the participant or the study
(e.g., subjects with active systemic infection, subjects with clinically significant
peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as
thrombocytopenia, hemophilia, or significant anemia).

17. Women of childbearing potential with a positive pregnancy test during screening OR
women who do not agree to remain on birth control until follow-up at 6 months OR
lactating women.

18. Subject has a known, unresolved history of drug use or alcohol dependency, lacks the
ability to comprehend or follow instructions, or would be unlikely or unable to comply
with study follow-up requirements.

19. Subject is currently enrolled in another investigational drug or device trial.

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
Phase 1
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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula Heart Centre - Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Prague
Country [4] 0 0
Denmark
State/province [4] 0 0
Aarhus
Country [5] 0 0
Italy
State/province [5] 0 0
Bari

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biosense Webster, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility
study to evaluate the safety and effectiveness of the investigational multi-electrode
ablation catheter and integrated ablation system to treat resistant hypertension.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01756300
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