Global SYMPLICITY Registry - Full Text View

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, renal insufficiency, etc. The Global Symplicity Registry will consecutively enroll 3000 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 Years Registry

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:	3000
Study Start Date:	February 2012
Estimated Study Completion Date:	July 2021
Estimated Primary Completion Date:	July 2017 (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 (Adult, Senior)
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 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kim BK, Böhm M, Mahfoud F, Mancia G, Park S, Hong MK, Kim HS, Park SJ, Park CG, Seung KB, Gwon HC, Choi DJ, Ahn TH, Kim CJ, Kwon HM, Esler M, Jang YS. Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea). J Hum Hypertens. 2016 May;30(5):315-21. doi: 10.1038/jhh.2015.77. Epub 2015 Jul 9.

Böhm M, Mahfoud F, Ukena C, Hoppe UC, Narkiewicz K, Negoita M, Ruilope L, Schlaich MP, Schmieder RE, Whitbourn R, Williams B, Zeymer U, Zirlik A, Mancia G; GSR Investigators. First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension. Hypertension. 2015 Apr;65(4):766-74. doi: 10.1161/HYPERTENSIONAHA.114.05010. Epub 2015 Feb 17.


Responsible Party:	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT01534299 History of Changes
Other Study ID Numbers:	10031728DOC
Study First Received:	February 13, 2012
Last Updated:	April 13, 2016
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 Kidney Diseases Renal Insufficiency, Chronic Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Heart Diseases Cardiovascular Diseases Urologic Diseases Renal Insufficiency

ClinicalTrials.gov processed this record on September 26, 2016