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Multipolar Mapping and Atrial Arrhythmias

Primary Purpose

Atrial Fibrillation or Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Constellation Full Contact Mapping Catheter
Sponsored by
Angelo Biviano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation or Atrial Flutter focused on measuring Atrial Fibrillation, Atrial Flutter, Multipolar Catheter, Atrial Arrhythmia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Basket Catheter

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2014
Last Updated
February 18, 2016
Sponsor
Angelo Biviano
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1. Study Identification

Unique Protocol Identification Number
NCT02307188
Brief Title
Multipolar Mapping and Atrial Arrhythmias
Official Title
Atrial Signal Analysis Using a Multipolar Catheter in Patients Undergoing Atrial Fibrillation and Flutter Ablations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Angelo Biviano

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation or Atrial Flutter
Keywords
Atrial Fibrillation, Atrial Flutter, Multipolar Catheter, Atrial Arrhythmia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basket Catheter
Arm Type
Experimental
Arm Description
The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Intervention Type
Device
Intervention Name(s)
Constellation Full Contact Mapping Catheter
Intervention Description
64-electrode intracardiac mapping catheter.
Primary Outcome Measure Information:
Title
Atrial Fibrillation Dominant Frequency
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo B Biviano, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Multipolar Mapping and Atrial Arrhythmias

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