Acute Carotid Sinus Endovascular Stimulation II Study

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Device: Baroreceptor Stimulation

• Registration Number: NCT01458483
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

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.

Study Timeline

• Study First Submitted: 2011-08-25
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baroreceptor Stimulation	Baroreceptor Stimulation	-

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure during electrical stimulation	Intraoperative testing only
Change in diastolic blood pressure during electrical stimulation	Intraoperative testing only

Secondary Outcome Measures

Name	Time	Method
Characterize number and type of side effects seen during stimulation	Intraoperative testing only