Acute Carotid Sinus Endovascular Stimulation II Study

NCT01458483 | Completed Phase 1

• 1 other identifier: ACES II
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in systolic blood pressure during electrical stimulation

  Intraoperative testing only

• Change in diastolic blood pressure during electrical stimulation

  Intraoperative testing only

Secondary Outcomes (1)

• Characterize number and type of side effects seen during stimulation

  Intraoperative testing only

Study Arms (1)

Baroreceptor Stimulation

EXPERIMENTAL

Device: Baroreceptor Stimulation

Interventions

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.

Baroreceptor Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Unknown Facility

Detroit, Michigan, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Randy Lieberman, M.D.

  Harper Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

US (1)