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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Internal Cardioversion; Procedure: External Cardioversion

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internal Cardioversion; Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol.	Procedure: Internal Cardioversion; Internal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol
Active Comparator: 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.	Procedure: External Cardioversion; External Cardioversion per institutional protocol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Kentucky
• Investigators: Study Chair: Samy C Elayi, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): October 23, 2018
• Study Completion (Actual): October 23, 2018

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 21, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: atrial fibrillation; cardioversion; implantable cardiac defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 16-0536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No