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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-10-23

Brief Summary

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

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Detailed Description

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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

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized in block fashion to either internal or external cardioversion

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internal Cardioversion

Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol.

Group Type EXPERIMENTAL

Internal Cardioversion

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

External Cardioversion

Intervention Type PROCEDURE

External Cardioversion per institutional protocol

Interventions

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Internal Cardioversion

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

Intervention Type PROCEDURE

External Cardioversion

External Cardioversion per institutional protocol

Intervention Type PROCEDURE

Eligibility Criteria

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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