Multipolar Mapping and Atrial Arrhythmias

Atrial Fibrillation or Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307188
• Other study ID #: AAAN3357
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: February 18, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation or Atrial Flutter
• Atrial Flutter

Intervention

Device:
• Constellation Full Contact Mapping Catheter
64-electrode intracardiac mapping catheter.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Angelo Biviano

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No