Multipolar Mapping and Atrial Arrhythmias

Study Overview
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Brief Summary
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This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.

Detailed Description
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Atrial fibrillation (AF) and atrial flutter (AFL) are the most common cardiac arrhythmias in adults, and account for a substantial portion of patient morbidity and healthcare expenditures. Great effort has been put forth to discover effective treatments for AF/FL. Promising results of catheter ablation suggest that AF/FL may be eliminated in a majority of patients. For example, data from numerous laboratories shows that up to 85 percent of patients with the paroxysmal form of AF may be free of recurrences and off anti-arrhythmic drugs at one year follow-up.

Official Title
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Atrial Signal Analysis Using a Multipolar Catheter in Patients Undergoing Atrial Fibrillation and Flutter Ablations

Conditions
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Atrial Fibrillation or Atrial Flutter

Intervention / Treatment
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* Device: Constellation Full Contact Mapping Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred to the PI (Dr. Biviano) or co-investigators in the Program of Cardiac Electrophysiology at Columbia University Medical Center who are scheduled to undergo ablation will be approached for recruitment: Older than 45 years of age History of AF and/or AFL and are candidates for catheter ablation. Exclusion Criteria: Patients not fitting the above clinical criteria or unwilling to comply with the instructions of the monitor are excluded, as well as patients with the following: Permanent leads or prosthetic or stenotic valves present Active systemic infection Echocardiographically-confirmed visual presence of thrombus For whom the inability of obtaining vascular access exists Heparin-induced thrombocytopenia Hemodynamic instability or shock

Ages Eligible for Study
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Minimum Age: 45 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 |
| --- | --- |
| Experimental: Basket Catheter<br>The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms. | Device: Constellation Full Contact Mapping Catheter<br>* 64-electrode intracardiac mapping catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation Dominant Frequency | Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Atrial Flutter, Multipolar Catheter, Atrial Arrhythmia