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

NCT03164395 | Completed

• 1 other identifier: 16-0536
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; implantable cardiac defibrillator; cardioversion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Internal Cardioversion

EXPERIMENTAL

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

Procedure: Internal Cardioversion

External Cardioversion

ACTIVE COMPARATOR

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

Interventions

Internal Cardioversion PROCEDURE

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

Internal Cardioversion

External Cardioversion PROCEDURE

External Cardioversion per institutional protocol

External Cardioversion

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• over the age of 99
• pregnant
• prisoner

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samy C Elayi, MD

  University of Kentucky

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 23, 2017
• Study Start: July 1, 2017
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)