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

This study is currently recruiting participants.
Verified June 2013 by University Hospital, Saarland
Sponsor:
ClinicalTrials.gov Identifier:
NCT01888315
First Posted: June 27, 2013
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Saarland
September 4, 2012
June 27, 2013
June 27, 2013
January 2011
January 2021   (Final data collection date for primary outcome measure)
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.

Same as current
No Changes Posted
  • 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.

Same as current
Not Provided
Not Provided
 
Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
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.

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.).
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Heart Failure
  • Chronic Kidney Disease
  • Diabetes
  • Heart Rhythm Disorders
  • 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.
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
January 2021
January 2021   (Final data collection date for primary outcome measure)

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.).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Felix Mahfoud, MD +4968411621346 felix.mahfoud@uks.eu
Contact: Michael Böhm, MD +4968411623372 michael.boehm@uks.eu
Germany
 
 
NCT01888315
Symplicity Extension
No
Not Provided
Not Provided
University Hospital, Saarland
University Hospital, Saarland
Not Provided
Study Director: Felix Mahfoud, MD University Hospital, Saarland
Principal Investigator: Michael Böhm, MD University Hospital, Saarland
University Hospital, Saarland
June 2013

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