Multipolar Mapping and Atrial Arrhythmias

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Atrial Fibrillation or Atrial Flutter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Basket Catheter

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

Group Type EXPERIMENTAL

Constellation Full Contact Mapping Catheter

Intervention Type DEVICE

64-electrode intracardiac mapping catheter.

Interventions

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Constellation Full Contact Mapping Catheter

64-electrode intracardiac mapping catheter.

Intervention Type DEVICE

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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No