Global SYMPLICITY Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medtronic Vascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01534299
First received: February 13, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Diabetes Mellitus
Heart Failure
Chronic Kidney Disease
Sleep Apnea
Device: Medtronic Renal Denervation System
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Global ProSpective RegistrY for SyMPathetic RenaL DenervatIon In Selected IndiCatIons Through 3-5 Years Registry

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • BP Measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)


Estimated Enrollment: 5000
Study Start Date: February 2012
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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")
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534299

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

Locations
Germany
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Saarlandes, Germany, D-66421
Contact: Michael Bohm, 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 Boehm, MD         
Sponsors and Collaborators
Medtronic Vascular
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01534299     History of Changes
Other Study ID Numbers: 10031728DOC
Study First Received: February 13, 2012
Last Updated: May 9, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Hypertension
Kidney Diseases
Sleep Apnea Syndromes
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 21, 2014