Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps

Study Overview
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Brief Summary
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The 64 pole basket catheter used for the mapping procedure will be defined atypical sites which sustain atrial fibrillation. The ablation through the driver will lead to more rapid ablation of the atrial fibrillation.

Detailed Description
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Atrial fibrillation (AF) is a common abnormal and rapid heart rhythm characterized by erratic electrical activity of the upper chambers of the heart. This cardiac arrhythmia may lead to stroke, heart failure, low blood pressure, chest pain, and increased mortality rate. Treatment may include medication to stop the rhythm abnormality, blood thinners, and/or ablation. Ablation involves application of heat or freezing to the area sustaining the rhythm abnormality. This requires tubes (catheters)to be placed in the heart. Human atrial fibrillation may be sustained by localized drivers (rapid and/or organized sites of atrial electrical activation). By mapping/recording the patient's specific atrial anatomy and atrial electrical activity with the 64-pole basket catheter, we may add to the knowledge base of these driver locations. We may also add to the knowledge about where best to ablate to terminate the arrhythmia. Typical anatomic

Official Title
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Recording for Potential AF Drivers and Patient Specific Atrial Anatomy and Atrial Electrogram Maps Using an FDA Approved 64-Pole Basket Catheter (CONFIRM)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: 64 pole basket catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at VCU Medical Center who are 21 years or older undergoing EPS for ablation of persistent AF (non-rheumatic) whose AF episodes last equal to or greater than 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours. Per current standard of care, AF patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation. Exclusion Criteria: Active coronary ischemic in the past year Rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk Prior ablation or cardiac surgery, that alters atrial electophysiology Left atrial clot or dense contrast on TEE, which would increase thromboembolic risk Out of range serum electrolytes, including K outside 4.0-5.0 mmol/1 Left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm Thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk Pregnancy Inability or unwillingness to provide informed consent Unable to converse in English Use of anti-arrhythmic drug less than 5 X half-life Prior ablation or cardiac surgery, that alters atrial electophysiology

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 64 pole basket catheter<br>all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation | Procedure: 64 pole basket catheter<br>* The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.<br>* Other names: Constellation basket catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Drivers in Right Atrial | To determine where atypical areas of drivers might be. | 30 min | 
| Time to Ablation of All Sources | total time taken to ablate all sources of rotors/focal sources in driver locations | 30 minutes | 
| Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources | percentage of patients | 30 minutes | 
| Average Number of Rotors/Focal Drivers in Diverse Locations |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs | To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers. | 30 min | 
| Mean Time to Recurrence of Atrial Fibrillation | mean time to recurrence of atrial fibrillation | 1 year | 
| Single-procedure Freedom From Atrial Fibrillation | percentage of patients without prior ablation | one year | 
| Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation | percentage of all patients who had ablation perfornmed | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, cardiac ablation