Acute Carotid Sinus Endovascular Stimulation II Study (ACES II)

Medtronic

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Device: Baroreceptor Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01458483

ACES II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Baroreceptor Stimulation

Experimental group

Treatment:

Device: Baroreceptor Stimulation