Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006433

Trial Description

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Title

Global ProSpective RegistrY for SyMPathetic RenaL DenervatIon In Selected IndiCatIons Through 3-5 Years Registry

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a prospective, multi-center, single-arm, non-interventional and open-label registry.
The purpose of the registry is to document the long-term safety and effectiveness of renal
denervation in a real world patient population with hypertension and gathering data for
other diseases characterized by elevated sympathetic drive, such as diabetes mellitus type
2, heart failure, renal insufficiency, etc. The Global Symplicity Registry will
consecutively enroll a minimum of 5,000 patients who undergo the renal denervation
procedure, from over 200 sites worldwide.

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Brief Summary in Scientific Language

This registry will collect data prospectively on patients that receive renal denervation and
treatment will be applied according to the 'Intended Use' in the IFU. The treatment will be
performed according to routine hospital practice and no additional tests are required
specific to the registry. This registry will serve as a tool to collect clinical data in
order to expand the knowledge base of safety, effectiveness and functionality of the
Medtronic renal denervation system in a real world patient population.

The key measures collected for the patients will be inclusive of, but are not limited to,
blood pressure measurements, change in medications, eGFR changes (based on the MDRD formula)
and clinical data pertaining to hypertension and individual disease state(s) characterized
by elevated sympathetic drive.

The inclusion criteria for the registry includes:

- Age ≥ 18 years or minimum age as required by local regulations

- The patient is an acceptable candidate for renal denervation based upon the
Instructions For Use for the Medtronic renal denervation system. The procedure must be
performed with an initial use, market-released Medtronic renal denervation catheter.

- The patient or legal representative has been informed of the nature of the registry has
consented to participate and authorized the collection and release of this medical
information by signing a consent form ("Patient Informed Consent Form" or "Patient Data
Release Authorization Form")

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Organizational Data

  •   DRKS00006433
  •   2014/10/10
  •   2012/02/13
  •   no
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Secondary IDs

  •   NCT01534299  (ClinicalTrials.gov)
  •   10031728DOC  (Medtronic Vascular)
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Health Condition or Problem studied

  •   Hypertension
  •   Diabetes Mellitus
  •   Heart Failure
  •   Chronic Kidney Disease
  •   Sleep Apnea
  •   I10 -  Essential (primary) hypertension
  •   E14 -  Unspecified diabetes mellitus
  •   I50 -  Heart failure
  •   N18 -  Chronic kidney disease
  •   G47.3 -  Sleep apnoea
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Interventions/Observational Groups

  •   Device: Medtronic Renal Denervation System
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   IV
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Primary Outcome

- BP Measurements; time frame: 6 months; Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/02/27
  •   5000
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion Criteria:

- Age ≥ 18 years or minimum age as required by local regulations

- The patient is an acceptable candidate for renal denervation based upon the
Instructions For Use for the Medtronic renal denervation system. The procedure must
be performed with an initial use, market-released Medtronic renal denervation
catheter.

- The patient or legal representative has been informed of the nature of the registry
has consented to participate and authorized the collection and release of this
medical information by signing a consent form ("Patient Informed Consent Form" or
"Patient Data Release Authorization Form")

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Exclusion Criteria

[---]*

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Addresses

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    • Medtronic Vascular
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    • K. Wandrey 
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  • start of 1:1-Block address public-contact
    • K. Wandrey 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/11/27


* This entry means the parameter is not applicable or has not been set.