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Paradym CRT 8770

Phase 3

Heart Failure | Unknown | Cardiovascular |LivaNova PLC|Last Updated: Jun 19, 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
NO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment520
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02167789Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT DevicePHASE3 COMPLETED 520Sep 1, 2009Jun 1, 2013Jun 19, 201450 United States, Canada +7
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Study Endpoints
Primary Endpoints
Number of HF related events
13 months
Secondary Endpoints
Co morbidities
13 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
PhDNO_INTERVENTION -
Interventions
NameTypeDescription
Paradym CRT 8770DEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy * Severe HF (NYHA Class III or IV) at the time of enrollment * At least one HF-related event (as defined for primary objective) within the last 6...

Countries:United StatesCanadaFranceGermanyItalyNetherlandsSpainSwitzerlandUnited Kingdom
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