Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
This trial is active, not recruiting.
|Treatment||medtronic multi-electrode radiofrequency (rf) renal denervation system|
|Start date||September 2012|
|End date||March 2014|
|Trial size||50 participants|
|Trial identifier||NCT01699529, 10058715DOC|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Melbourne, Australia||Alfred Hospital||no longer recruiting|
|Melbourne, Australia||St. Vincent's Hospital Melbourne||no longer recruiting|
|Melbourne, Australia||Epworth Hospital||no longer recruiting|
|Wellington, New Zealand||Wellington Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Acute safety as measured by procedural complications
time frame: 1 month
Change in Office Systolic Blood Pressure
time frame: Baseline to 6 months
Male or female participants from 18 years up to 80 years old.
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. 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.
|Official title||Multi-electrode Radiofrequency Renal Denervation System Feasibility Study|
|Principal investigator||Robert Whitbourn, MD|
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