Status:
COMPLETED
Acute Carotid Sinus Endovascular Stimulation II Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The Acute Carotid Sinus Endovascular Stimulation II (ACES II) Study is a multicenter, prospective, non-randomized study that is being conducted to evaluate the feasibility of endovascular stimulation ...
Detailed Description
All study objectives are being assessed during the intraoperative baroreceptor stimulation. No subsequent testing will be performed. The follow-up visit is only intended to assess for adverse events.
Eligibility Criteria
Inclusion
- Subject is at least 18 years old
- 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
- Subject has an ejection fraction (EF) less than 35% (by most recent echocardiography in the past 6 months) and there has been no change in clinical status relative to EF
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01458483
Start Date
October 1 2011
End Date
October 1 2012
Last Update
October 30 2012
Active Locations (1)
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1
Detroit, Michigan, United States