Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
1 other identifier
interventional
50
2 countries
4
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 26, 2016
October 1, 2016
1.5 years
September 21, 2012
October 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Acute safety as measured by procedural complications
1 month
Secondary Outcomes (1)
Change in Office Systolic Blood Pressure
Baseline to 6 months
Study Arms (1)
Renal Denervation
EXPERIMENTALInterventions
The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Alfred Hospital
Melbourne, Victoria, 3004, Australia
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065, Australia
Epworth Hospital
Melbourne, Victoria, 3069, Australia
Wellington Hospital
Wellington, Wellington Region, New Zealand
Related Publications (1)
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.
PMID: 25982652DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Whitbourn, MD
St Vincent's Hospital Melbourne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2012
First Posted
October 3, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2014
Study Completion
October 1, 2016
Last Updated
October 26, 2016
Record last verified: 2016-10