Recruiting

Defibrillation Testing

Sponsor:

The Cooper Health System

Code:

NCT01905007

Conditions

Ventricular Arrhythmias

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Defibrillation testing

Study Details

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

Study ID

NCT01905007

Start date

Dec, 2010

Status verified date

Jul, 2013

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Defibrillation testing

Defibrillation testing at initial ICD implantation

no intervention: No defibrillation testing

No defibrillation testing at initial ICD implantation

Interventions

Defibrillation testing

Defibrillation testing at initial ICD implantation

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Andrea M. Russo, MD

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

Julie Field

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

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Andrea M. Russo, M.D.

856-968-7096

Julie Field

856-669-8847Field-Julie@cooperhealth.edu

Principal Investigator:

Andrea M. Russo, MD

More Information

Sponsor

The Cooper Health System

Last update posted

Jul 22, 2013

Last verified

Jul, 2013

Keywords

  • Implantable cardioverter defibrillator
  • Defibrillation threshold testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2013-07-22.