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
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Procedure: Internal Cardioversion Procedure: External Cardioversion|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized in block fashion to either internal or external cardioversion|
|Masking:||None (Open Label)|
|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|
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
- 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
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
|Contact: Samy C Elayi, MDfirstname.lastname@example.org|
|Contact: Kevin W Parrott, MDemail@example.com|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40506|
|Contact: Samy C Elayi, MD 859-323-5479 firstname.lastname@example.org|
|Study Chair:||Samy C Elayi, MD||University of Kentucky|