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Completed

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Detroit, Michigan, United States

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

Device

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.

Primary outcomes

  1. Change in systolic blood pressure during electrical stimulation

    Time frame: Intraoperative testing only

  2. Change in diastolic blood pressure during electrical stimulation

    Time frame: Intraoperative testing only

Secondary outcomes

  1. 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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