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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Internal Cardioversion; Procedure: External Cardioversion

• Registration Number: NCT03164395
• Lead Sponsor: University of Kentucky

Brief 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.

Study Timeline

• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-05-21
• Study First Posted: 2017-05-23
• Study Start: 2017-07-01
• Primary Completion: 2018-10-23
• Study Completion: 2018-10-23
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal Cardioversion	Internal Cardioversion	Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol.
External Cardioversion	External Cardioversion	Patients randomized to internal cardioversion will have a maximum energy shock delivered from the device between the RV coil and can. If cardioversion is not successful they will then undergo external cardioversion per institutional protocol.

Primary Outcome Measures

Name	Time	Method
Acute Conversion of Atrial Fibrillation to Sinus Rhythm	Immediate	Does the patient return for at least one beat to sinus rhythm following the administration of a shock

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States