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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Device: Baroreceptor Stimulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Carotid Sinus Endovascular Stimulation II Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Characterize number and type of side effects seen during stimulation [ Time Frame: Intraoperative testing only ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baroreceptor Stimulation 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458483

Locations
United States, Michigan
Detroit, Michigan, United States
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Randy Lieberman, M.D. Harper Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01458483     History of Changes
Other Study ID Numbers: ACES II
Study First Received: August 25, 2011
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013