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Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

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ClinicalTrials.gov Identifier: NCT01888315
Recruitment Status : Unknown
Verified June 2013 by University Hospital, Saarland.
Recruitment status was:  Recruiting
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
Safety and efficacy of renal denervation [ Time Frame: Baseline to 6 months ]
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
  • Effect of renal denervation on different organ systems. [ Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
    Myocardial function and geometry using echo and MRI. Heart rate changes and arrhythmias. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
  • Safety and efficacy of renal denervation [ Time Frame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
    Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
Official Title  ICMJE Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
Brief Summary The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.
Detailed Description

Inclusion Criteria

  1. Individual is 18 years of age.
  2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
  3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

  1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
  2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Heart Failure
  • Chronic Kidney Disease
  • Diabetes
  • Heart Rhythm Disorders
Intervention  ICMJE
  • Device: Renal denervation with Symplicity Flex Medtronic/Ardian
    Renal denervation using CE-marked devices will be performed according to best medical practice.
  • Device: Renal denervation with EnligHTN St. Jude Medical
    Renal denervation using CE-marked devices will be performed according to best medical practice.
  • Device: Renal denervation with Paradise Recor
    Renal denervation using CE-marked devices will be performed according to best medical practice.
  • Device: Renal denervation with V2 Vessix
    Renal denervation using CE-marked devices will be performed according to best medical practice.
Study Arms  ICMJE
  • Experimental: Catheter-based renal denervation

    One procedure will be performed using one of the CE-marked devices for renal denervation:

    Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix

    Interventions:
    • Device: Renal denervation with Symplicity Flex Medtronic/Ardian
    • Device: Renal denervation with EnligHTN St. Jude Medical
    • Device: Renal denervation with Paradise Recor
    • Device: Renal denervation with V2 Vessix
  • No Intervention: Medical therapy
    Best medical therapy using guideline recommended drugs in each disease state.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 24, 2013)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Individual is 18 years of age.
  2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
  3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

  1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
  2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888315
Other Study ID Numbers  ICMJE Symplicity Extension
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Saarland
Study Sponsor  ICMJE University Hospital, Saarland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Felix Mahfoud, MD University Hospital, Saarland
Principal Investigator: Michael Böhm, MD University Hospital, Saarland
PRS Account University Hospital, Saarland
Verification Date June 2013

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