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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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2011-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Baroreceptor Stimulation
Baroreceptor Stimulation
The stimulation catheter may be placed in different locations within the IJV at the level of the cervical spine vertebrae. Stimulation amplitudes will be varied from 0.1 mA to 20 mA.
Interventions
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Baroreceptor Stimulation
The stimulation catheter may be placed in different locations within the IJV at the level of the cervical spine vertebrae. Stimulation amplitudes will be varied from 0.1 mA to 20 mA.
Eligibility Criteria
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Inclusion Criteria
* Subject is hypertensive (defined as at least one in-office Systolic BP measurement ≥140 mm Hg or Diastolic BP ≥90 mm Hg within three months prior to enrollment
* Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures.
* Subject (or subject's legally authorized representative) is able and wiling to give informed consent
Exclusion Criteria
* Subject is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
* Subject is enrolled or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the Medtronic study manager, documenting that there is not a concern that co-enrollment could confound the results of this trial.
* Subject is unable or unwilling to participate with study procedures
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Randy Lieberman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Harper Hospital
Locations
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Detroit, Michigan, United States
Countries
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Related Links
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Other Identifiers
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ACES II
Identifier Type: -
Identifier Source: org_study_id