Rapid Renal Sympathetic Denervation for Resistant Hypertension II
NCT ID: NCT01939392
Last Updated: 2015-08-18
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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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2013-09-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Renal Denervation
Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication.
Renal Denervation (OneShot™ Renal Denervation System)
Optimal Medical Therapy
Subjects randomized to the control arm will be maintained on antihypertensive medications.
No interventions assigned to this group
Interventions
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Renal Denervation (OneShot™ Renal Denervation System)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable drug regimen including three or more anti-hypertensive medications including a diuretic
Exclusion Criteria
* Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
* Patient has Type I diabetes
* Has scheduled or planned surgery within the next 6 months
* Individual is pregnant nursing or plans to be pregnant
18 Years
75 Years
ALL
No
Sponsors
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Medtronic Endovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Dierk Scheinert, MD
Role: PRINCIPAL_INVESTIGATOR
Park-Krankenhaus Liepzig
Guiseppe Mancia, MD
Role: PRINCIPAL_INVESTIGATOR
Universita Minano-Bicocca, Ospedale San Gerardo di Monza
Locations
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Hospital San Raffaele
Milan, , Italy
Countries
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Other Identifiers
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CP-1003
Identifier Type: -
Identifier Source: org_study_id
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