Back to resultsMultipolar 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
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
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
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
Learn more about this trial
Multipolar Mapping and Atrial Arrhythmias
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