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Catheter-based cardiac cryoablation

Phase 3

Atrial Flutter | Unknown | Other |Boston Scientific Corporation|Last Updated: Feb 24, 2011

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 Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00113178Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial FlutterPHASE3 COMPLETED 160Jan 1, 2004Jun 1, 2005Feb 24, 2011 -
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Study Endpoints
Primary Endpoints
Acute efficacy
Acute safety
Secondary Endpoints
Long-term efficacy
Long-term safety
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Catheter-based cardiac cryoablationDEVICE -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Symptomatic atrial flutter Exclusion Criteria: * Prior ablation * Contraindication to intervention * Poor general health

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