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CRT-SonR 9770

Phase 3

Heart Failure | Unknown | Cardiovascular |LivaNova PLC|Last Updated: Jun 18, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

CRT-SonR 9770 · 1 trial · 1 indication

Phase 3 1
NCT01169272Clinical Evaluation Of The SonR Atrial Lead In Paradym RF DeviceHeart Failure
COMPLETED100 Analytics
PHASE3COMPLETED
Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of the SonR lead safety
3 months

Complication free rate of the SonR lead superior to 90 %

Secondary Endpoints

Incidence of adverse events
12 months
ICD electrical performances
12 months
Evaluation of the SonR atrial lead performance
3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
CRT-SonR 9770EXPERIMENTALActive implantable defibrillator with ability to cardiac resynchronization therapy

Interventions

NameTypeDescription
CRT-SonR 9770DEVICEActive implantable defibrillator with capacity of cardiac resynchronization therapy
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Eligibility Criteria

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

Inclusion Criteria: * Patient eligible for implantation of a CRT 9770 device accordingly to the relevant currently-approved ACC/AHA/ESC guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber ICD * Implanted with atrial SonR lead * Signed...

Countries:France
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Frequently asked questions about CRT-SonR 9770

What is CRT-SonR 9770 used for?

CRT-SonR 9770 is an investigational device used for heart failure. It is a cardiac resynchronization therapy system that includes the SonR atrial lead and the Paradym RF device. It is currently in Phase 3 clinical development for this indication.

Who makes CRT-SonR 9770?

CRT-SonR 9770 is developed by LivaNova PLC, a company listed on the NASDAQ under the ticker symbol LIVN. The device is being studied for the treatment of heart failure.

What phase is CRT-SonR 9770 in?

CRT-SonR 9770 is in Phase 3 clinical development. It is an investigational device and is not yet approved for commercial use. A Phase 3 clinical trial has been completed to evaluate its safety and effectiveness in patients with heart failure.

What clinical trials is CRT-SonR 9770 in?

CRT-SonR 9770 has one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT01169272. The trial, titled 'Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device,' enrolled 100 participants with heart failure in France.

Is CRT-SonR 9770 the same as the SonR atrial lead?

CRT-SonR 9770 is a cardiac resynchronization therapy system that includes the SonR atrial lead and the Paradym RF device. The SonR atrial lead is a component of the CRT-SonR 9770 system, which is being evaluated for heart failure.