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SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01418261
First received: August 15, 2011
Last updated: April 24, 2017
Last verified: April 2017
August 15, 2011
April 24, 2017
September 2011
December 2013   (Final data collection date for primary outcome measure)
Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ]
Primary Effectiveness Outcome Measure
  • Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ]
    Primary Effectiveness Outcome Measure
  • Major Adverse Events [ Time Frame: Baseline to 1 month post-randomization ]
    Primary Safety Outcome Measure
Complete list of historical versions of study NCT01418261 on ClinicalTrials.gov Archive Site
Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ]
Same as current
Not Provided
Not Provided
 
SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Uncontrolled Hypertension
  • Device: Renal denervation (Symplicity Catheter System)
  • Diagnostic Test: Renal angiogram
  • Experimental: Renal Denervation
    Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
    Interventions:
    • Device: Renal denervation (Symplicity Catheter System)
    • Diagnostic Test: Renal angiogram
  • Sham Comparator: Control group
    Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications
    Intervention: Diagnostic Test: Renal angiogram

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
535
February 17, 2017
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individual is ≥ 18 and ≤ 80 years old at time of randomization.
  • Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
  • Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit

Exclusion Criteria:

  • Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
  • Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
  • 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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01418261
IP125
Yes
Not Provided
Plan to Share IPD: No
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: George Bakris, MD Professor of Medicine, Hypertension Center Director University of Chicago Medical Center
Principal Investigator: Deepak L Bhatt, MD, MPH VA Boston Healthcare System Department of Cardiology
Medtronic Vascular
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP