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Cardiac Resynchronization Therapy

Phase 3

Heart Failure | Unknown | Cardiovascular |Abbott Laboratories|Last Updated: Feb 4, 2019

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
RandomizedDouble-BlindUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00132977RethinQ Study - Evaluating Pacing in Heart Failure PatientsPHASE3 COMPLETED 250Jul 1, 2005Jul 1, 2007Feb 4, 201934 United States
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Study Endpoints
Primary Endpoints
Cardiac resynchronization therapy (CRT) effectiveness will be evaluated in terms of exercise capacity (peak VO2), as measured by cardiopulmonary exercise testing
6 months
Safety will be evaluated in terms of survival from CRT-D system-related complications.
6 months
Secondary Endpoints
Quality of Life Questionnaire
6 months
New York Heart Association (NYHA) Classification
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Cardiac Resynchronization TherapyDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Have an approved indication for implantation of an ICD. * Have advanced HF with a New York Heart Association (NYHA) Classification of III, despite receiving optimal pharmacological therapy. * Have a stable heart failure medical regimen. * Have a left ventricular ejection fract...

Countries:United States
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