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Enrollment challenges
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The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation with either the CARTO® 3 or the NavX(TM) System.
It is hypothesized that described features will reduce the median radiation exposure during the CARTO® 3 system-guided procedures compared to the NavX(TM) system-guided procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carto 3 | Those subjects whose cases use the CARTO 3 EP Navigation System. |
| |
| NAVX | Those subjects whose cases use the NAVX(TM) EP Navigational System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Mapping | Device | Generating a cardiac map using the study device (CARTO 3) compared to the control device (NAVX[TM]) and measuring the amount of radiation exposure duration for each. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fluoroscopy Time | The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures. | Throughout the Total Duration of the Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Time | Total Duration of the Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects referred for Radiofrequency ablation treatment for paroxysmal atrial fibrillation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Island Health Authority - Royal Jubilee Hospital | Victoria | British Columbia | V8R 1J8 | Canada | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Carto 3 | Those subjects whose cases use the CARTO 3 EP Navigation System. |
| FG001 | NAVX | Those subjects whose cases use the NAVX(TM) EP Navigational System. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carto 3 | Those subjects whose cases use the CARTO 3 EP Navigation System. |
| BG001 | NAVX | Those subjects whose cases use the NAVX(TM) EP Navigational System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Total Fluoroscopy Time | The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures. | Posted | Median | Full Range | minutes | Throughout the Total Duration of the Procedure |
|
Throughout the Duration of the 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 | Carto 3 | Those subjects whose cases use the CARTO 3 EP Navigation System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Perforation | Cardiac disorders | Non-systematic Assessment | Not related to imaging technology |
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The study was terminated early, with 107 enrolled and 93 evaluable subjects, due to difficulty enrolling despite prolonged extension of the enrollment period. The original design called for 176 enrolled and 122 evaluable patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tina Hunter, Consulting Statistician to Biosense Webster | CTI Clinical Trials and Consulting | 513-619-5541 | tinah@s2stats.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| QE II Health Sciences Center |
| Halifax |
| Nova Scotia |
| B3H 3Q7 |
| Canada |
| London Health Sciences | London | Ontario | N6A 5A5 | Canada |
| Southlake Regional Healthcare Centre | Newmarket | Ontario | L3Y8C3 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Laval Hopital | Québec | Quebec | G1V 4G5 | Canada |
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Total Procedure Time | Posted | Median | Full Range | minutes | Total Duration of the Procedure |
|
|
|
| 1 |
| 46 |
| 0 |
| 46 |
| EG001 | NAVX | Those subjects whose cases use the NAVX(TM) EP Navigational System. | 3 | 47 | 0 | 47 |
|
| Cardiac Tamponade | Cardiac disorders | Non-systematic Assessment | Not related to imaging technology |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |