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

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ClinicalTrials.gov Identifier: NCT03164395
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Samy C Elayi, MD, University of Kentucky

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Internal Cardioversion Procedure: External Cardioversion Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized in block fashion to either internal or external cardioversion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Acute Conversion of Atrial Fibrillation to Sinus Rhythm [ Time Frame: Immediate ]
    Does the patient return for at least one beat to sinus rhythm following the administration of a shock



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164395


Contacts
Contact: Samy C Elayi, MD 859-323-5479 samy.claude.elayi@uky.edu
Contact: Kevin W Parrott, MD 8593231667 kevin.parrott@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Samy C Elayi, MD    859-323-5479    samy.claude.elayi@uky.edu   
Sponsors and Collaborators
University of Kentucky
Investigators
Study Chair: Samy C Elayi, MD University of Kentucky

Responsible Party: Samy C Elayi, MD, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03164395     History of Changes
Other Study ID Numbers: 16-0536
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samy C Elayi, MD, University of Kentucky:
atrial fibrillation
implantable cardiac defibrillator
cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes