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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Andrea M. Russo, MD, Cooper University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01905007
First Posted: July 22, 2013
Last Update Posted: July 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medtronic
University of Washington
Information provided by (Responsible Party):
Andrea M. Russo, MD, Cooper University Hospital
  Purpose
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.

Condition Intervention Phase
Ventricular Arrhythmias Device: Defibrillation testing Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Test-No Test" Implantable Cardioverter Defibrillator Pilot Study (TNT-ICD)

Resource links provided by NLM:


Further study details as provided by Andrea M. Russo, MD, Cooper University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Defibrillation testing
Defibrillation testing at initial ICD implantation
Device: Defibrillation testing
Defibrillation testing at initial ICD implantation
Other Name: Medtronic implantable cardioverter defibrillator
No Intervention: No defibrillation testing
No defibrillation testing at 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905007


Contacts
Contact: Andrea M. Russo, MD 856-968-7096 russo-andrea@cooperhealth.edu
Contact: Julie Field 856-669-8847 field-julie@cooperhealth.edu

Locations
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Andrea M. Russo, M.D.    856-968-7096      
Contact: Julie Field    856-669-8847    Field-Julie@cooperhealth.edu   
Principal Investigator: Andrea M. Russo, MD         
Sub-Investigator: John Andriulli, MD         
Sub-Investigator: Matthew Ortman, MD         
Sub-Investigator: Claudine Pasquarello, PA-C         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Jeanne Poole, MD         
Principal Investigator: Jeanne Poole, MD         
Sponsors and Collaborators
The Cooper Health System
Medtronic
University of Washington
Investigators
Principal Investigator: Andrea M. Russo, MD The Cooper Health System
  More Information

Publications:

Responsible Party: Andrea M. Russo, MD, Professor of Medicine, Director of Electrophysiology & Arrhythmia Services, Cooper University Hospital
ClinicalTrials.gov Identifier: NCT01905007     History of Changes
Other Study ID Numbers: CUH-09-087
First Submitted: February 24, 2012
First Posted: July 22, 2013
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by Andrea M. Russo, MD, Cooper University Hospital:
Implantable cardioverter defibrillator
Defibrillation threshold testing