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Global SYMPLICITY Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Medtronic Vascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01534299
First received: February 13, 2012
Last updated: November 3, 2014
Last verified: November 2014

February 13, 2012
November 3, 2014
February 2012
August 2016   (final data collection date for primary outcome measure)
BP Measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)
Same as current
Complete list of historical versions of study NCT01534299 on ClinicalTrials.gov Archive Site
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Global SYMPLICITY Registry
Global ProSpective RegistrY for SyMPathetic RenaL DenervatIon In Selected IndiCatIons Through 3-5 Years Registry

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.

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")
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Subjects undergoing renal denervation procedure to treat the diseases affected by increased sympathetic activity.

  • Hypertension
  • Diabetes Mellitus
  • Heart Failure
  • Chronic Kidney Disease
  • Sleep Apnea
Device: Medtronic Renal Denervation System
The Symplicity renal denervation system is comprised of a single-use, disposable catheter and a reusable radiofrequency (RF) generator. The Symplicity renal denervation system has CE Marking for the intended use of delivering low-level radiofrequency energy through the wall of the renal artery to denervate the human kidney.
Renal Denervation Treatment
All patients treated with renal denervation procedure will be enrolled as part of this single arm registry
Intervention: Device: Medtronic Renal Denervation System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
July 2021
August 2016   (final data collection date for primary outcome measure)

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")
Both
18 Years and older
No
Contact: K. Wandrey rs.medtroniccardiovascularclinicaltrials@medtronic.com
Germany
 
NCT01534299
10031728DOC
No
Medtronic Vascular
Medtronic Vascular
Not Provided
Not Provided
Medtronic Vascular
November 2014

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