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

"Test-No Test" Implantable Cardioverter Defibrillator Pilot Study (TNT-ICD)

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.

Study Overview

• Status: Unknown
• Conditions: Ventricular Arrhythmias
• Intervention / Treatment: Device: Defibrillation testing

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Hospital
      • Contact: Julie Field; Phone Number: 856-669-8847; Email: Field-Julie@cooperhealth.edu
      • Contact: Andrea M. Russo, M.D.; Phone Number: 856-968-7096
      • Principal Investigator: Andrea M. Russo, MD
      • Sub-Investigator: John Andriulli, MD
      • Sub-Investigator: Matthew Ortman, MD
      • Sub-Investigator: Claudine Pasquarello, PA-C
  • Washington
    • Seattle, Washington, United States, 98195
      • Not yet recruiting
      • University of Washington
      • Contact: Jeanne Poole, MD
      • Principal Investigator: Jeanne Poole, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Defibrillation testing; Defibrillation testing at initial ICD implantation	Device: Defibrillation testing; Defibrillation testing at initial ICD implantation; Other Names: Medtronic implantable cardioverter defibrillator
NO_INTERVENTION: No defibrillation testing; No defibrillation testing at initial ICD implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Collaborators: University of Washington; Medtronic
• Investigators: Principal Investigator: Andrea M. Russo, MD, The Cooper Health System

Publications and helpful links

General Publications

• Russo AM, Sauer W, Gerstenfeld EP, Hsia HH, Lin D, Cooper JM, Dixit S, Verdino RJ, Nayak HM, Callans DJ, Patel V, Marchlinski FE. Defibrillation threshold testing: is it really necessary at the time of implantable cardioverter-defibrillator insertion? Heart Rhythm. 2005 May;2(5):456-61. doi: 10.1016/j.hrthm.2005.01.015.
• Swerdlow CD, Russo AM, Degroot PJ. The dilemma of ICD implant testing. Pacing Clin Electrophysiol. 2007 May;30(5):675-700. doi: 10.1111/j.1540-8159.2007.00730.x.
• Mainigi SK, Cooper JM, Russo AM, Nayak HM, Lin D, Dixit S, Gerstenfeld EP, Hsia HH, Callans DJ, Marchlinski FE, Verdino RJ. Elevated defibrillation thresholds in patients undergoing biventricular defibrillator implantation: incidence and predictors. Heart Rhythm. 2006 Sep;3(9):1010-6. doi: 10.1016/j.hrthm.2006.05.028. Epub 2006 Jun 15.
• Blatt JA, Poole JE, Johnson GW, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Anderson J, Chung K, Wong WS, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators. No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2008 Aug 12;52(7):551-6. doi: 10.1016/j.jacc.2008.04.051.
• Birnie D, Tung S, Simpson C, Crystal E, Exner D, Ayala Paredes FA, Krahn A, Parkash R, Khaykin Y, Philippon F, Guerra P, Kimber S, Cameron D, Healey JS. Complications associated with defibrillation threshold testing: the Canadian experience. Heart Rhythm. 2008 Mar;5(3):387-90. doi: 10.1016/j.hrthm.2007.11.018. Epub 2007 Nov 28.
• Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol. 2006 Feb;17(2):140-5. doi: 10.1111/j.1540-8167.2005.00294.x.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (ESTIMATE): July 22, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 22, 2013
• Last Update Submitted That Met QC Criteria: July 17, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Defibrillation threshold testing; Implantable cardioverter defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CUH-09-087