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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01520506




Registration number
NCT01520506
Ethics application status
Date submitted
25/01/2012
Date registered
27/01/2012
Date last updated
14/08/2015

Titles & IDs
Public title
Rapid Renal Sympathetic Denervation for Resistant Hypertension
Scientific title
Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
Secondary ID [1] 0 0
CIP 012
Universal Trial Number (UTN)
Trial acronym
RAPID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Resistant to Conventional Therapy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Covidien OneShot™ System

Experimental: Rapid Renal Denervation -


Treatment: Devices: Covidien OneShot™ System
Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.

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

Outcomes
Primary outcome [1] 0 0
Acute Procedural Safety - Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:
SAE's related to groin and vascular access complications, and
SAE's related to renal artery injury.
Timepoint [1] 0 0
One Week
Secondary outcome [1] 0 0
Chronic Procedural Safety - Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Renal Denervation Procedure Effectiveness - Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline
Timepoint [2] 0 0
From baseline to 6 months

Eligibility
Key inclusion criteria
1. Systolic blood pressure = 160 mmHg despite treatment with a regimen of 3 or more
anti-hypertensive medications that includes a diuretic and that has been stable for 2
weeks prior to screening.

2. Age 18-85 years.

3. Able to provide informed consent and comply with follow-up visits.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diameter of left or right renal artery less than 4 mm or greater than 7mm.

2. Length of target segment of left or right renal artery less than 20mm.

3. Other renal arterial abnormalities including severe renal artery stenosis, previous
renal stenting or angioplasty.

4. End-stage renal disease requiring dialysis or renal transplant.

5. estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m2.

6. Type 1 diabetes mellitus.

7. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months
prior to screening.

8. Severe valvular heart disease for which reduction of blood pressure would be
considered hazardous.

9. Bleeding disorder or refusing blood transfusions.

10. Pregnancy or breast feeding.

11. Peripheral vascular disease precluding catheter insertion.

12. Any serious medical condition, which in the opinion of the investigator, may adversely
affect the safety or effectiveness of the participant or the study.

13. Current enrollment in another investigational drug or device Study.

Study design
Purpose of the study
Treatment
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
Phase
Phase 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
Germany
State/province [3] 0 0
Bonn
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt
Country [5] 0 0
Germany
State/province [5] 0 0
Hamburg
Country [6] 0 0
Germany
State/province [6] 0 0
Heidelberg
Country [7] 0 0
Germany
State/province [7] 0 0
Münster
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Luxembourg
State/province [9] 0 0
Luxembourg
Country [10] 0 0
Netherlands
State/province [10] 0 0
Eindhoven
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nieuwegein
Country [12] 0 0
Netherlands
State/province [12] 0 0
Rotterdam
Country [13] 0 0
Netherlands
State/province [13] 0 0
Utrecht
Country [14] 0 0
New Zealand
State/province [14] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Endovascular
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medtronic - MITG
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Meditrial Europe Ltd.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy
through the wall of the renal artery to denervate the human kidney.
Trial website
https://clinicaltrials.gov/show/NCT01520506
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
W.A.L. Tonino, MD
Address 0 0
Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands
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

No data has been provided for results reporting
Summary results
Other publications