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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01905007
Other study ID # CUH-09-087
Secondary ID
Status Recruiting
Phase Phase 4
First received February 24, 2012
Last updated July 17, 2013
Start date December 2010
Est. completion date December 2014

Study information

Verified date July 2013
Source The Cooper Health System
Contact Andrea M. Russo, MD
Phone 856-968-7096
Email russo-andrea@cooperhealth.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial ICD implantation.


Description:

Implantable cardioverter-defibrillators (ICDs) are the most effective treatment for the primary and secondary prevention of sudden cardiac death (SCD). At the time of ICD implantation, ventricular fibrillation (VF) is typically induced to demonstrate effective arrhythmia termination by the implanted device. Although defibrillation threshold (DFT) testing with induction of VF at time of ICD insertion is currently considered the "standard of care," and instructions for usage of devices approved by the Food and Drug Administration (FDA) include labeling with DFT testing, the value of defibrillation testing with modern-day devices has been questioned. Defibrillation testing can be associated with serious complications and may add to the cost of the procedure.

It is hypothesized that patients who do not undergo defibrillation testing will have outcomes similar to those who do undergo defibrillation testing at the time of initial implantation. This pilot study is being performed to determine the feasibility of performing a larger, multi-center clinical trial with longer follow-up to investigate whether or not defibrillation testing will have any impact on overall mortality, implant complications, or long-term first shock efficacy during clinical follow-up.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Defibrillation testing
Defibrillation testing at initial ICD implantation

Locations

Country Name City State
United States Cooper University Hospital Camden New Jersey
United States University of Washington Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
The Cooper Health System Medtronic, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary Composite all-cause mortality and operative complications The composite endpoint of implant complications and mortality rates will be compared in the DFT vs. no DFT groups. Procedure-related complications will be defined as those occurring within 90 days post-implantation and mortality will be measured at 2 year follow-up Yes
Secondary 1st shock efficacy for clinical occurrence of ventricular tachycardia (VT)/VF The efficacy of 1st shock therapy for VT/VF will be compared between the DFT and no DFT groups. 2 years Yes
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