Global SYMPLICITY Registry (GSR) DEFINE

• ClinicalTrials.gov Identifier: NCT01534299
• Recruitment Status: Recruiting
• First Posted: February 16, 2012
• Last Update Posted: October 20, 2022
• Sponsor: Medtronic Vascular
• Information provided by (Responsible Party): Medtronic Vascular

Study Description

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 GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.

Condition or disease	Intervention/treatment
Hypertension	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 .

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

• Study Type: Observational
• Estimated Enrollment: 5000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
• Actual Study Start Date: February 2012
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: October 2027

Groups and Cohorts

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

Primary Outcome Measures :

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

Eligibility Criteria

• 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 for hypertension

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

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

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

Mahfoud F, Mancia G, Schmieder RE, Ruilope L, Narkiewicz K, Schlaich M, Williams B, Ribichini F, Weil J, Kao HL, Rodriguez-Leor O, Noory E, Ong TK, Unterseeh T, de Araujo Goncalves P, Zirlik A, Almerri K, Sharif F, Lauder L, Wanten M, Fahy M, Bohm M. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. J Am Coll Cardiol. 2022 Nov 15;80(20):1871-1880. doi: 10.1016/j.jacc.2022.08.802.

Mahfoud F, Mancia G, Schmieder R, Narkiewicz K, Ruilope L, Schlaich M, Whitbourn R, Zirlik A, Zeller T, Stawowy P, Cohen SA, Fahy M, Bohm M. Renal Denervation in High-Risk Patients With Hypertension. J Am Coll Cardiol. 2020 Jun 16;75(23):2879-2888. doi: 10.1016/j.jacc.2020.04.036.

Mahfoud F, Bakris G, Bhatt DL, Esler M, Ewen S, Fahy M, Kandzari D, Kario K, Mancia G, Weber M, Bohm M. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017 Jan 7;38(2):93-100. doi: 10.1093/eurheartj/ehw325.

Linz D, Mancia G, Mahfoud F, Narkiewicz K, Ruilope L, Schlaich M, Kindermann I, Schmieder RE, Ewen S, Williams B, Bohm M; Global SYMPLICITY Registry Investigators. Renal artery denervation for treatment of patients with self-reported obstructive sleep apnea and resistant hypertension: results from the Global SYMPLICITY Registry. J Hypertens. 2017 Jan;35(1):148-153. doi: 10.1097/HJH.0000000000001142.

Kim BK, Bohm 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.

Bohm 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
• Other Study ID Numbers: 10031728DOC
• First Posted: February 16, 2012
• Last Update Posted: October 20, 2022
• Last Verified: October 2022

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases