search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internal Cardioversion
External Cardioversion
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, implantable cardiac defibrillator, cardioversion

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internal Cardioversion

External Cardioversion

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2017
Last Updated
March 20, 2019
Sponsor
University of Kentucky
search

1. Study Identification

Unique Protocol Identification Number
NCT03164395
Brief Title
The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation
Official Title
The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, implantable cardiac defibrillator, cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in block fashion to either internal or external cardioversion
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal Cardioversion
Arm Type
Experimental
Arm Description
Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol.
Arm Title
External Cardioversion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Internal Cardioversion
Intervention Description
Internal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol
Intervention Type
Procedure
Intervention Name(s)
External Cardioversion
Intervention Description
External Cardioversion per institutional protocol
Primary Outcome Measure Information:
Title
Acute Conversion of Atrial Fibrillation to Sinus Rhythm
Description
Does the patient return for at least one beat to sinus rhythm following the administration of a shock
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samy C Elayi, MD
Organizational Affiliation
University of Kentucky
Official's Role
Study Chair
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs