Hypertension
Conditions
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 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.
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.
Interventions
DEVICEBaroreceptor 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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure during electrical stimulation | Intraoperative testing only |
| Change in diastolic blood pressure during electrical stimulation | Intraoperative testing only |
Secondary
| Measure | Time frame |
|---|---|
| Characterize number and type of side effects seen during stimulation | Intraoperative testing only |
Countries
United States
Outcome results
None listed