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OpenTrials
Completed

NCT Number: NCT02307188

Multipolar Mapping and Atrial Arrhythmias

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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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constellation Full Contact Mapping Catheter

Device

64-electrode intracardiac mapping catheter.

Primary outcomes

  1. Atrial Fibrillation Dominant Frequency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Angelo Biviano

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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