The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.
This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be employed to reduce systolic and diastolic blood pressure at 6 months as compared to pre-treatment baseline blood pressures. Patient blood pressure will be measured by in the office according to recognized international techniques and standards. Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
146
percutaneous renal denervation using the Vessix RF balloon catheter
St. Vincent's Hospital
Sydney, New South Wales, Australia
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment
Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .
Time frame: Baseline and 6 months
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure
Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.
Time frame: Baseline and 6 months
Absence of Flow Limiting Stenosis in the Renal Artery
Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound
Time frame: 6 months
Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery
Time frame: Duration of the procedure (average of 65 minutes)
Renal Artery Infarction or Embolus
Time frame: Duration of the procedure (average of 65 minutes)
Cerebrovascular Accident (CVA) at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
Myocardial Infarction at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
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Sudden Cardiac Death at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
Angiographically-documented Renal Stenosis Requiring an Intervention
Time frame: 2 Years
Chronic Symptomatic Orthostatic Hypotension
Time frame: 2 Years
Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)
Time frame: 2 Years
Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%
Time frame: 2 Years