Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation

Ventricular Arrhythmias Clinical Trial

— TNT-ICD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01905007
• Other study ID #: CUH-09-087
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Ventricular Arrhythmias

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)

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. — View Citation

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. — View Citation

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. Epub 2006 Jun 15. — View Citation

Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol. 2006 Feb;17(2):140-5. — View Citation

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. — View Citation

Swerdlow CD, Russo AM, Degroot PJ. The dilemma of ICD implant testing. Pacing Clin Electrophysiol. 2007 May;30(5):675-700. Review. — View Citation

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