Multipolar Mapping and Atrial Arrhythmias

Not Applicable

Completed

Conditions: Atrial Fibrillation or Atrial Flutter

Interventions: Device: Constellation Full Contact Mapping Catheter

Registration Number: NCT02307188

Lead Sponsor: Angelo Biviano

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basket Catheter	Constellation Full Contact Mapping Catheter	The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation Dominant Frequency	1 year	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.

Secondary Outcome Measures