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CRT-SonR 9770

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01169272Clinical Evaluation Of The SonR Atrial Lead In Paradym RF DevicePHASE3 COMPLETED 100Oct 1, 2010Jun 1, 2012Jun 18, 20141 France
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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 — 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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