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Ardian Symplicity Catheter

Phase 1

Hypertension | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Nov 5, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

Ardian Symplicity Catheter · 1 trial · 1 indication

Phase 1 1
NCT00483808Renal Denervation in Patients With Refractory HypertensionHypertension
COMPLETED73 Analytics
PHASE1COMPLETED
Renal Denervation in Patients With Refractory Hypertension
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide confirmation that renal denervation is safe and feasible.
3 years

Secondary Endpoints

Evidence of renal denervation; indication of physiologic response; assessment of device performance.
3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
DenervationEXPERIMENTALRenal denervation using the Symplicty Catheter

Interventions

NameTypeDescription
Ardian Symplicity™ CatheterDEVICERenal denervation using the Symplicity Catheter
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * \>= 18 years of age. * a systolic blood pressure of 160 mmHg or greater. * receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening. * agrees to have the study procedure(s) performed and additional proce...

Countries:AustraliaPoland
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Frequently asked questions about Ardian Symplicity Catheter

What is Ardian Symplicity Catheter used for?

Ardian Symplicity Catheter is an investigational device being studied for the treatment of hypertension, specifically in patients with refractory hypertension. It is a catheter-based approach being evaluated in clinical research for its potential role in managing high blood pressure that does not respond adequately to standard therapies.

Who makes Ardian Symplicity Catheter?

Ardian Symplicity Catheter is being developed by Medtronic plc, a medical technology company publicly traded under the ticker symbol MDT on the New York Stock Exchange. The company is conducting clinical research to evaluate the device's safety and effectiveness in treating hypertension.

What phase is Ardian Symplicity Catheter in?

Ardian Symplicity Catheter is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. The device is currently being studied in early-stage clinical trials to assess its safety and potential efficacy in patients with refractory hypertension.

What clinical trials is Ardian Symplicity Catheter in?

Ardian Symplicity Catheter has been studied in one completed clinical trial with the identifier NCT00483808, titled 'Renal Denervation in Patients With Refractory Hypertension.' This Phase 1 study enrolled 73 participants with hypertension at sites in Australia and Poland. The trial has been completed, and no active trials are currently listed.

Is Ardian Symplicity Catheter the same as renal denervation?

Ardian Symplicity Catheter is a device used in a procedure called renal denervation, which is the therapeutic approach being investigated in the clinical trial NCT00483808. The catheter is the tool used to perform the denervation procedure, which aims to treat refractory hypertension by modulating renal nerve activity.