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Acute Carotid Sinus Endovascular Stimulation II Study (ACES II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01458483
First received: August 25, 2011
Last updated: October 29, 2012
Last verified: October 2012

August 25, 2011
October 29, 2012
October 2011
October 2012   (final data collection date for primary outcome measure)
  • Change in systolic blood pressure during electrical stimulation [ Time Frame: Intraoperative testing only ] [ Designated as safety issue: No ]
  • Change in diastolic blood pressure during electrical stimulation [ Time Frame: Intraoperative testing only ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01458483 on ClinicalTrials.gov Archive Site
Characterize number and type of side effects seen during stimulation [ Time Frame: Intraoperative testing only ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acute Carotid Sinus Endovascular Stimulation II Study
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Device: Baroreceptor 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.
Experimental: Baroreceptor Stimulation
Intervention: Device: Baroreceptor Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01458483
ACES II
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Principal Investigator: Randy Lieberman, M.D. Harper Hospital
Medtronic Cardiac Rhythm Disease Management
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP