Clinical Trials Directory

Trials / Completed

CompletedNCT03164395

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
31 (actual)
Sponsor
University of Kentucky · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREInternal CardioversionInternal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol
PROCEDUREExternal CardioversionExternal Cardioversion per institutional protocol

Timeline

Start date
2017-07-01
Primary completion
2018-10-23
Completion
2018-10-23
First posted
2017-05-23
Last updated
2019-03-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03164395. Inclusion in this directory is not an endorsement.