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Global SYMPLICITY Registry
This study is currently recruiting participants.
Verified April 2017 by Medtronic Vascular
Sponsor:
Medtronic Vascular
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01534299
First received: February 13, 2012
Last updated: April 12, 2017
Last verified: April 2017
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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 |
|---|---|
| Hypertension Diabetes Mellitus Heart Failure Chronic Kidney Disease Sleep Apnea | Device: Medtronic Renal Denervation System |
| 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 ]Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)
| Estimated Enrollment: | 3000 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | April 2021 |
| Estimated Primary Completion Date: | November 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) |
| 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
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
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):
| 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 12, 2017 |
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 June 27, 2017