Detroit, Michigan, United States
NCT Number: NCT01458483
Acute Carotid Sinus Endovascular Stimulation II Study
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 of carotid sinus nerves via an electrophysiology (EP) catheter advanced into the internal jugular vein (IJV). The current study investigates the hypothesis that intraoperative electrical stimulation of the carotid sinus from the IJV will result in an acute and dose-dependent reduction in blood pressure and heart rate.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
Baroreceptor Stimulation
DeviceThe 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.
Primary outcomes
-
Change in systolic blood pressure during electrical stimulation
Time frame: Intraoperative testing only
-
Change in diastolic blood pressure during electrical stimulation
Time frame: Intraoperative testing only
Secondary outcomes
-
Characterize number and type of side effects seen during stimulation
Time frame: Intraoperative testing only
Sponsors and collaborators
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Industry
Registry information
Acronym: ACES II
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 24, 2011
- Registry last updated
- Oct 30, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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