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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Cooper Health System
Sponsor:
Collaborators:
Medtronic
University of Washington
Information provided by (Responsible Party):
Andrea M. Russo, MD, Cooper University Hospital
ClinicalTrials.gov Identifier:
NCT01905007
First received: February 24, 2012
Last updated: July 17, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 The Cooper Health System:

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 24, 2012
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cooper Health System:
Implantable cardioverter defibrillator
Defibrillation threshold testing

ClinicalTrials.gov processed this record on September 16, 2014