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Baroreceptor Stimulation

Phase 1

Hypertension | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Oct 30, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

Baroreceptor Stimulation · 1 trial · 1 indication

Phase 1 1
NCT01458483Acute Carotid Sinus Endovascular Stimulation II StudyHypertension
COMPLETED9 Analytics
PHASE1COMPLETED
Acute Carotid Sinus Endovascular Stimulation II Study
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Characterize number and type of side effects seen during stimulation
Intraoperative testing only
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Baroreceptor StimulationEXPERIMENTAL -

Interventions

NameTypeDescription
Baroreceptor StimulationDEVICEThe 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 catheteriz...

Countries:United States
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Frequently asked questions about Baroreceptor Stimulation

What is Baroreceptor Stimulation used for?

Baroreceptor Stimulation is an investigational therapy being studied for the treatment of hypertension, a condition of chronically elevated blood pressure. It is delivered through an endovascular approach that stimulates the carotid sinus, which is part of the body's blood pressure regulation system. The therapy is currently in early-stage clinical development.

Who makes Baroreceptor Stimulation?

Baroreceptor Stimulation is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker symbol MDT. Medtronic is conducting clinical research to evaluate the safety and effectiveness of this therapy for hypertension.

What phase is Baroreceptor Stimulation in?

Baroreceptor Stimulation is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials. The Phase 1 study has been completed, and the therapy remains in early-stage development for hypertension.

What clinical trials is Baroreceptor Stimulation in?

Baroreceptor Stimulation has one completed clinical trial registered under NCT01458483, titled "Acute Carotid Sinus Endovascular Stimulation II Study." This Phase 1 study enrolled 9 participants with hypertension in the United States. The trial was uncontrolled, meaning there was no comparison group, and it has been completed.

How does Baroreceptor Stimulation work?

Baroreceptor Stimulation works by electrically stimulating the carotid sinus, which contains baroreceptors that sense blood pressure. This stimulation triggers a reflex that helps lower blood pressure. The therapy is delivered endovascularly, meaning through a catheter inserted into a blood vessel, targeting the carotid sinus area.