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Completed

NCT Number: NCT03164395

The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation

This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

About this study

This study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion, but the presence of the SVC defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. Currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. Internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. External cardioversion may carry a small risk of damaged to the CIED.

The investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • greater than 18 years of age
  • persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion
  • have an implantable cardiac defibrillator

Exclusion criteria

  • over the age of 99
  • pregnant
  • prisoner

Treatment and study plan

Internal Cardioversion

Procedure

Internal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol

External Cardioversion

Procedure

External Cardioversion per institutional protocol

Primary outcomes

  1. Acute Conversion of Atrial Fibrillation to Sinus Rhythm

    Time frame: Immediate

    Does the patient return for at least one beat to sinus rhythm following the administration of a shock

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Registry information

Official study title

The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 23, 2017
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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