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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03164395
Enrollment
31
Registered
2017-05-23
Start date
2017-07-01
Completion date
2018-10-23
Last updated
2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, implantable cardiac defibrillator, cardioversion

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.

Interventions

PROCEDUREExternal Cardioversion

External Cardioversion per institutional protocol

PROCEDUREInternal Cardioversion

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

Sponsors

University of Kentucky
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute Conversion of Atrial Fibrillation to Sinus RhythmImmediateDoes the patient return for at least one beat to sinus rhythm following the administration of a shock

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026