Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000987965
Ethics application status
Approved
Date submitted
14/09/2011
Date registered
16/09/2011
Date last updated
13/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Maya Renal Hypertension Ablation System Study
Scientific title
Low Level RF Renal Ablation in Chronic Hypertensive Patients to Treat Resistancy to Anti Hypertensive Medication By Lowering Systolic Blood Pressure
Secondary ID [1] 263040 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension 270769 0
Condition category
Condition code
Cardiovascular 270952 270952 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Balloon Catheter delivers low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney. The treatment time is approximately 2 minutes. Catheter is removed from the body at the end of procedure.
Intervention code [1] 269384 0
Treatment: Devices
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279622 0
Ability to insert the balloon catheter and place it within the renal artery and safely remove it from the body.
Timepoint [1] 279622 0
Procedure
Primary outcome [2] 279636 0
Ability to deliver low level RF energy to the renal artery.
Timepoint [2] 279636 0
Procedure
Primary outcome [3] 279638 0
Measuring the RF energy delivered and the duration of energy delivered.
Timepoint [3] 279638 0
Procedure
Secondary outcome [1] 294053 0
Blood Pressure Reduction will be assessed by measuring blood pressure with a standard sphygmomanometer or manual measurement system. Three separate measurements will be averaged to yield the clinical assessment.
Timepoint [1] 294053 0
6 months

Eligibility
Key inclusion criteria
Subject has a systolic blood pressure greater than or equal to 160 mmHg
Subject is on 2 or more anti hypertensive medications
Bilateral Renal Arteries must be between 4-7mm diameter and greater than 20mm in length
Subject signs informed consent and agrees to follow up visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject has a glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD calculation.
Subject has had a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit.
Subject has history of bleeding diathesis or coagulopathy, Type 1 diabetes, renal artery stenosis, valve disease, planned surgery or intervention in coming 6 months, allergy to listed drugs in protocol, is pregnant, or has peripheral disease precluding a 9F sheath introducer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2011
Actual
2/11/2011
Date of last participant enrolment
Anticipated
Actual
7/03/2012
Date of last data collection
Anticipated
Actual
27/06/2013
Sample size
Target
10
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 3841 0
New Zealand
State/province [1] 3841 0

Funding & Sponsors
Funding source category [1] 269846 0
Other Collaborative groups
Name [1] 269846 0
Maya Medical
Country [1] 269846 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
Maya Medical
Address
18729 Metler Court
Saratoga, California 95070
Country
United States of America
Secondary sponsor category [1] 268873 0
Individual
Name [1] 268873 0
Mike Kolber Regulatory Affairs Maya Medical
Address [1] 268873 0
18729 Metler Court
Saratoga, California 95070
Country [1] 268873 0
United States of America
Other collaborator category [1] 252254 0
Commercial sector/Industry
Name [1] 252254 0
PCRG
Address [1] 252254 0
Pacific Clinical Research Group Pty Limited
Suite G03,1 Cassins Avenue
North Sydney Sydney NSW 2060
Australia
Country [1] 252254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271815 0
Mercy Angiography Mercy Hospital Ethics Committee
Ethics committee address [1] 271815 0
Ethics committee country [1] 271815 0
New Zealand
Date submitted for ethics approval [1] 271815 0
03/09/2011
Approval date [1] 271815 0
26/10/2011
Ethics approval number [1] 271815 0
NTX/11/09/091

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2500 2500 0 0
/AnzctrAttachments/347477-HDEC_Letter_-_14STH37AM01_Approved_Notification_of_Conclusion_of_Study.pdf (Ethics approval)

Contacts
Principal investigator
Name 33155 0
Dr John Ormiston
Address 33155 0
Mercy Angiography
Auckland, NZ
Country 33155 0
New Zealand
Phone 33155 0
+6421921351
Fax 33155 0
Email 33155 0
[email protected]
Contact person for public queries
Name 16402 0
Laura Minarsch
Address 16402 0
430 forest avenue
laguna Beach, California 92651
Country 16402 0
United States of America
Phone 16402 0
+0019494945048
Fax 16402 0
+0019494940557
Email 16402 0
[email protected]
Contact person for scientific queries
Name 7330 0
Dr. Michel Accad
Address 7330 0
2000 Van Ness Ave
Suite 208
San Francisco, CA 94109
Country 7330 0
United States of America
Phone 7330 0
+0014153772868
Fax 7330 0
+0019494940557
Email 7330 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.