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CONTAK RENEWAL 3 AVT

Phase 3

Heart Failure | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Sep 29, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

CONTAK RENEWAL 3 AVT · 1 trial · 2 indications

Phase 3 1
NCT00158977CONTAK RENEWAL 3 AVTHeart Failure
COMPLETED73 Analytics
PHASE3COMPLETED
CONTAK RENEWAL 3 AVT
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
3 months
Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion
3 months
Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms
3 months

Secondary Endpoints

Safety Endpoint: Ventricular Fibrillation (VF) Detection Time
3 months
Safety Endpoint: Percent BiV Pacing
3 months
Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate
3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CONTAK RENEWAL 3 AVTDEVICECONTAK RENEWAL 3 AVT
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Eligibility Criteria

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

Inclusion Criteria: Patients who meet the following criteria should be given consideration for inclusion in the clinical investigation: * Meet all device indications and contraindications * Willing and capable of providing informed consent, undergoing a device implant, participating in all testing...

Countries:United States
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Frequently asked questions about CONTAK RENEWAL 3 AVT

What is CONTAK RENEWAL 3 AVT used for?

CONTAK RENEWAL 3 AVT is a cardiac device used for heart failure, specifically in patients with atrial fibrillation. It was studied in a Phase 3 clinical trial for these conditions. The device is intended to treat heart failure in this patient population.

Who makes CONTAK RENEWAL 3 AVT?

CONTAK RENEWAL 3 AVT is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. Boston Scientific is the developer of this cardiac device for heart failure.

What phase is CONTAK RENEWAL 3 AVT in?

CONTAK RENEWAL 3 AVT is in Phase 3 clinical development. The Phase 3 trial, identified as NCT00158977, has been completed. This device is investigational and not yet approved for commercial use.

What clinical trials is CONTAK RENEWAL 3 AVT in?

CONTAK RENEWAL 3 AVT has one completed Phase 3 clinical trial, registered as NCT00158977. The trial enrolled 73 participants with heart failure and atrial fibrillation in the United States. It was an uncontrolled, non-randomized study that has been completed.

Is CONTAK RENEWAL 3 AVT the same as CONTAK RENEWAL 3?

CONTAK RENEWAL 3 AVT is a specific model within the CONTAK RENEWAL 3 family of cardiac devices. The AVT designation indicates it is designed for patients with atrial fibrillation. It is a distinct version of the device tailored for this indication.