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CRT-D

Phase 2

Heart Failure | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Jun 25, 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment170

FDA Designations

No designations recorded

Clinical trial landscape

CRT-D · 1 trial · 5 indications

Phase 2 1
NCT00180336Safety and Efficacy Study of RENEWAL 4 AVTHeart Failure
COMPLETED170 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of RENEWAL 4 AVT
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months

Secondary Endpoints

LVESD at 6 months
Six-minute walk at 6 months
NYHA at 6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CRT-DDEVICE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Indications for the device * Availability for follow-up at an approved Field Following center, at the protocol defined intervals * Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation * Prescribed to st...

Countries:Germany
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Frequently asked questions about CRT-D

What is CRT-D used for in heart failure?

CRT-D is a cardiac resynchronization therapy defibrillator used for heart failure. It is being studied for conditions including heart failure, tachycardia, atrial fibrillation, atrial flutter, and ventricular fibrillation. The device is intended to coordinate heart contractions and deliver defibrillation when needed.

Who makes CRT-D?

CRT-D is developed by Boston Scientific Corporation, a company traded on the New York Stock Exchange under the ticker BSX. Boston Scientific is the sponsor of the clinical trial evaluating this device for heart failure and related cardiac arrhythmias.

What phase is CRT-D in?

CRT-D is in Phase 2 clinical development. A Phase 2 study has been completed, and the device remains investigational for the treatment of heart failure and associated arrhythmias. It is not yet approved for commercial use.

What clinical trials is CRT-D in?

CRT-D has one completed clinical trial, NCT00180336, titled 'Safety and Efficacy Study of RENEWAL 4 AVT.' This Phase 2 study enrolled 170 participants in Germany and evaluated the device in patients with heart failure, tachycardia, atrial fibrillation, atrial flutter, and ventricular fibrillation.

Is CRT-D the same as RENEWAL 4 AVT?

CRT-D is associated with the RENEWAL 4 AVT device, as indicated by the clinical trial title 'Safety and Efficacy Study of RENEWAL 4 AVT.' The trial evaluates CRT-D, and RENEWAL 4 AVT appears to be the specific model or system name for this cardiac resynchronization therapy defibrillator.