Atrial Fibrillation or Atrial Flutter
Conditions
Keywords
Atrial Fibrillation, Atrial Flutter, Multipolar Catheter, Atrial Arrhythmia
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.
Interventions
DEVICEConstellation Full Contact Mapping Catheter
64-electrode intracardiac mapping catheter.
Sponsors
Angelo Biviano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Dominant Frequency | 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. |
Countries
United States
Participant flow
Recruitment details
Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic activated clotting time levels \< 300 seconds (3 patients) or presence of prosthetic valve (1 patient).
Participants by arm
| Arm | Count |
|---|---|
| Basket Catheter The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Basket Catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: 1 year
Population: Because the quality of intracardiac electrogram data for the one patient to complete the study was not sufficient for analysis, this outcome measure was not analyzed.