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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basket Catheter | Experimental | The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constellation Full Contact Mapping Catheter | Device | 64-electrode intracardiac mapping catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Angelo B Biviano, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Since enrollment began, a total of five (5) patients consented to enrollment in the study during their atrial fibrillation/tachycardia ablation procedures. The catheter (a new catheter was used for each patient) was used in the left atrium in one patient who met all inclusion criteria and did not have any exclusions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to the paucity and lack of quality of intracardiac electrogram information collected from the one patient for whom the catheter was used in the left atrium, the collected electrogram data were not analyzed further.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 1 year |
|
Potential adverse events were collected at time of catheter insertion up to 1 day after procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. No adverse events related to this catheter were noted. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abgelo Biviano | Columbia University Medical Center | 212-305-7646 | ab542@columbia.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |