Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation

NCT01905007 | Unknown Phase 4 DMC

• 1 other identifier: CUH-09-087
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular Arrhythmias

Keywords

Implantable cardioverter defibrillator; Defibrillation threshold testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 1st shock efficacy for clinical occurrence of ventricular tachycardia (VT)/VF

  2 years

Study Arms (2)

Defibrillation testing

ACTIVE COMPARATOR

Defibrillation testing at initial ICD implantation

Device: Defibrillation testing

No defibrillation testing

NO INTERVENTION

No defibrillation testing at initial ICD implantation

Interventions

Defibrillation testing DEVICE

Defibrillation testing at initial ICD implantation

Also known as: Medtronic implantable cardioverter defibrillator

Defibrillation testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cooper Health System: lead
• Medtronic: collaborator
• University of Washington: collaborator

Study Sites (2)

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

NOT YET RECRUITING

Related Publications (6)

• 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.

  PMID: 15840466 BACKGROUND

• 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.

  PMID: 17461879 BACKGROUND

• 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.

  PMID: 16945792 BACKGROUND

• 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.

  PMID: 18687249 BACKGROUND

• 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.

  PMID: 18243813 BACKGROUND

• 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.

  PMID: 16533250 BACKGROUND

Study Officials

• Andrea M. Russo, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea M. Russo, MD

CONTACT

856-968-7096; russo-andrea@cooperhealth.edu

Julie Field

CONTACT

856-669-8847; field-julie@cooperhealth.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director of Electrophysiology & Arrhythmia Services

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: July 22, 2013
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 22, 2013

Record last verified: 2013-07

Locations

US (2)