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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01888315 |
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Date of registration:
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04/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
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Scientific title:
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Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01888315 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Felix Mahfoud, MD |
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Address:
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Telephone:
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+4968411621346 |
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Email:
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felix.mahfoud@uks.eu |
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Affiliation:
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Name:
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Felix Mahfoud, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Saarland |
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Name:
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Michael Böhm, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Saarland |
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Name:
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Michael Böhm, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Individual is 18 years of age.
2. Individual agrees to have all procedures performed, and is competent and willing to
provide written, informed consent to participate in the registry.
3. Patient scheduled for renal sympathetic denervation using market-released device.
Exclusion Criteria
1. In the eyes of the treating physician, the renal artery anatomy would interfere with
safe cannulation of the renal artery or meets local standards for surgical repair.
2. Individual has any serious medical condition, which in the opinion of the treating
physician may adversely affect the safety and/or effectiveness of the participant
(i.e., patients with clinically significant peripheral vascular disease, abdominal
aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant
anemia, etc.).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Diabetes
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Chronic Kidney Disease
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Heart Rhythm Disorders
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Heart Failure
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Intervention(s)
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Device: Renal denervation with Symplicity Flex Medtronic/Ardian
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Device: Renal denervation with Paradise Recor
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Device: Renal denervation with EnligHTN St. Jude Medical
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Device: Renal denervation with V2 Vessix
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Primary Outcome(s)
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Safety and efficacy of renal denervation
[Time Frame: Baseline to 6 months]
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Secondary Outcome(s)
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Effect of renal denervation on different organ systems.
[Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months]
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Safety and efficacy of renal denervation
[Time Frame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months]
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Secondary ID(s)
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Symplicity Extension
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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