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Global SYMPLICITY Registry

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ClinicalTrials.gov Identifier: NCT01534299
Recruitment Status : Recruiting
First Posted : February 16, 2012
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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Brief Summary:
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, renal insufficiency, etc. The Global Symplicity Registry will consecutively enroll 3000 patients who undergo the renal denervation procedure, from over 200 sites worldwide.

Condition or disease Intervention/treatment
Hypertension Diabetes Mellitus Heart Failure Chronic Kidney Disease Sleep Apnea Device: Medtronic Renal Denervation System

Detailed Description:

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")

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry
Study Start Date : February 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : March 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Renal Denervation Treatment
All patients treated with renal denervation procedure will be enrolled as part of this single arm registry
 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.


Outcome Measures
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Primary Outcome Measures :
  1. BP Measurements [ Time Frame: 6 months ]
    Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing renal denervation procedure to treat the diseases affected by increased sympathetic activity.
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")
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534299


Contacts
Contact: K. Wandrey rs.medtroniccardiovascularclinicaltrials@medtronic.com

Locations
Germany
Universitätsklinikum des Saarlandes Recruiting
Homburg, Saarlandes, Germany, D-66421
Contact: Michael Böhm, MD    (+49) 6841-1623372    michael.boehm@uniklinikum-saarland.de   
Contact: Felix Mahfoud, MD    +49 6841 16 21346    felix.mahfoud@uniklinikum-saarland.de   
Principal Investigator: Michael Böhm, MD         
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Michael Böhm, Prof. University Hospital, Saarland
Principal Investigator: Giuseppe Mancia, Prof. San Gerardo Hospital, Monza, Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01534299     History of Changes
Other Study ID Numbers: 10031728DOC
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency