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Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation (TNT-ICD)

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ClinicalTrials.gov Identifier: NCT01905007
Recruitment Status : Unknown
Verified July 2013 by Andrea M. Russo, MD, The Cooper Health System.
Recruitment status was:  Recruiting
First Posted : July 22, 2013
Last Update Posted : July 22, 2013
Sponsor:
Collaborators:
Medtronic
University of Washington
Information provided by (Responsible Party):
Andrea M. Russo, MD, The Cooper Health System

Tracking Information
First Submitted Date  ICMJE February 24, 2012
First Posted Date  ICMJE July 22, 2013
Last Update Posted Date July 22, 2013
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
Composite all-cause mortality and operative complications [ Time Frame: Procedure-related complications will be defined as those occurring within 90 days post-implantation and mortality will be measured at 2 year follow-up ]
The composite endpoint of implant complications and mortality rates will be compared in the DFT vs. no DFT groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
1st shock efficacy for clinical occurrence of ventricular tachycardia (VT)/VF [ Time Frame: 2 years ]
The efficacy of 1st shock therapy for VT/VF will be compared between the DFT and no DFT groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation
Official Title  ICMJE "Test-No Test" Implantable Cardioverter Defibrillator Pilot Study (TNT-ICD)
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Arrhythmias
Intervention  ICMJE Device: Defibrillation testing
Defibrillation testing at initial ICD implantation
Other Name: Medtronic implantable cardioverter defibrillator
Study Arms  ICMJE
  • Active Comparator: Defibrillation testing
    Defibrillation testing at initial ICD implantation
    Intervention: Device: Defibrillation testing
  • No Intervention: No defibrillation testing
    No defibrillation testing at initial ICD implantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 17, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Initial ICD implantation (single, dual, or CRT) for a standard Class I or Class II indication according to the ACC/AHA/HRS practice guidelines
  • Anticipated life expectancy >6 months

Exclusion Criteria:

  • Contraindications to defibrillation testing as determined by the managing physician*
  • ICD replacement implants
  • Right-sided pectoral implants
  • Abdominal implants
  • Chronic oral amiodarone therapy (for >6 weeks and continued need for amiodarone)
  • Inability to give informed consent

    • Contraindications to defibrillation testing include the following: hemodynamic instability, LA thrombus, atrial fibrillation without adequate anticoagulation, LV thrombus, recent CVA or TIA, severe unrevascularized coronary artery disease or unstable angina, severe aortic stenosis, inotropic dependence, patient refusal, other patient-specific medical conditions that are deemed as contraindications, as determined by the implanting physician.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01905007
Other Study ID Numbers  ICMJE CUH-09-087
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea M. Russo, MD, The Cooper Health System
Study Sponsor  ICMJE The Cooper Health System
Collaborators  ICMJE
  • Medtronic
  • University of Washington
Investigators  ICMJE
Principal Investigator: Andrea M. Russo, MD The Cooper Health System
PRS Account The Cooper Health System
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP