Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
NCT ID: NCT01888315
Last Updated: 2013-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
1000 participants
INTERVENTIONAL
2011-01-31
2021-01-31
Brief Summary
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Detailed Description
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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.).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Catheter-based renal denervation
One procedure will be performed using one of the CE-marked devices for renal denervation:
Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix
Renal denervation with Symplicity Flex Medtronic/Ardian
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with EnligHTN St. Jude Medical
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with Paradise Recor
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with V2 Vessix
Renal denervation using CE-marked devices will be performed according to best medical practice.
Medical therapy
Best medical therapy using guideline recommended drugs in each disease state.
No interventions assigned to this group
Interventions
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Renal denervation with Symplicity Flex Medtronic/Ardian
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with EnligHTN St. Jude Medical
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with Paradise Recor
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with V2 Vessix
Renal denervation using CE-marked devices will be performed according to best medical practice.
Eligibility Criteria
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Inclusion Criteria
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
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.).
18 Years
ALL
No
Sponsors
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University Hospital, Saarland
OTHER
Responsible Party
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Principal Investigators
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Felix Mahfoud, MD
Role: STUDY_DIRECTOR
University Hospital, Saarland
Michael Böhm, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Saarland
Locations
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University Hospital Saarland
Homburg/Saar, , Germany
Countries
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Central Contacts
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Facility Contacts
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Michael Böhm, MD
Role: primary
Felix Mahfoud, MD
Role: backup
References
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Lauder L, Siwy J, Mavrogeorgis E, Keller F, Kunz M, Wachter A, Emrich IE, Bohm M, Mischak H, Mahfoud F. Impact of Renal Denervation on Urinary Peptide-Based Biomarkers in Hypertension. Hypertension. 2024 Jun;81(6):1374-1382. doi: 10.1161/HYPERTENSIONAHA.124.22819. Epub 2024 Apr 4.
Other Identifiers
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Symplicity Extension
Identifier Type: -
Identifier Source: org_study_id
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