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T-Wave Alternans test

Phase 3

Ischemic Cardiomyopathy | Unknown | Cardiovascular |Abbott Laboratories|Last Updated: Jul 13, 2023

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment618
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00187291Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)PHASE3 COMPLETED 618Apr 1, 2001Jul 1, 2006Jul 13, 2023 -
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Study Endpoints
Primary Endpoints
Ventricular tachyarrhythmic events
12 months
Secondary Endpoints
Total Mortality
12 months
Ventricular tachyarrhythmic events below rate detection of the ICD
12 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
T-Wave Alternans testDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: Patients with no previous history of life threatening ventricular arrhythmias or symptomatic non-sustained VT, and who meet the following inclusion criteria may be enrolled in the study: 1. Ischemic heart disease as documented by any of the following: previous myocardial infarc...

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