Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation

NCT ID: NCT01905007

Last Updated: 2013-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Ventricular Arrhythmias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Defibrillation testing

Defibrillation testing at initial ICD implantation

Group Type: ACTIVE_COMPARATOR

Defibrillation testing

Intervention Type: DEVICE

Defibrillation testing at initial ICD implantation

No defibrillation testing

No defibrillation testing at initial ICD implantation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Defibrillation testing

Defibrillation testing at initial ICD implantation

Intervention Type: DEVICE

Other Intervention Names

Medtronic implantable cardioverter defibrillator

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Andrea M. Russo, MD

Professor of Medicine, Director of Electrophysiology & Arrhythmia Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea M. Russo, MD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Health System

Locations

Cooper University Hospital

Camden, New Jersey, United States

Site Status: RECRUITING

University of Washington

Seattle, Washington, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Andrea M. Russo, MD

Role: CONTACT

russo-andrea@cooperhealth.edu

856-968-7096

Julie Field

Role: CONTACT

field-julie@cooperhealth.edu

856-669-8847

Facility Contacts

Andrea M. Russo, M.D.

Role: primary

856-968-7096

Julie Field

Role: backup

Field-Julie@cooperhealth.edu

856-669-8847

Jeanne Poole, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 15840466 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17461879 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16945792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18687249 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18243813 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16533250 (View on PubMed)

Other Identifiers

CUH-09-087

Identifier Type: -

Identifier Source: org_study_id