Multipolar Mapping and Atrial Arrhythmias

Angelo Biviano

Status: Completed

Conditions: Atrial Fibrillation or Atrial Flutter

Treatments: Device: Constellation Full Contact Mapping Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02307188

AAAN3357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Basket Catheter

Experimental group

Description:

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

Treatment:

Device: Constellation Full Contact Mapping Catheter