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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Saarland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01888315
First received: September 4, 2012
Last updated: June 24, 2013
Last verified: June 2013

September 4, 2012
June 24, 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 ] [ Designated as safety issue: Yes ]

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
Complete list of historical versions of study NCT01888315 on ClinicalTrials.gov Archive Site
  • Effect of renal denervation on different organ systems. [ Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.).
Both
18 Years and older
No
Contact: Felix Mahfoud, MD +4968411621346 felix.mahfoud@uks.eu
Contact: Michael Böhm, MD +4968411623372 michael.boehm@uks.eu
Germany
 
NCT01888315
Symplicity Extension
No
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