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The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP + PVI ablation | Active Comparator | This study contains only one arm, which is GP ablation + PV antrum isolation. The intervention (GP ablation + PV isolation) was performed using ThermoCool Navistar catheters in all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP ablation + PV isolation | Device | All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Tachyarrhythmia Recurrence in Participants | Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation. | 0-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Significant Ablation Procedure Related Complications | Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke. | 0-1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunny Po, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GP Ablation + PV Isolation | All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | PV Isolation + GP Ablation | All patients received pulmonary vein antrum isolation (PV isolation) and ablation of the major atrial ganglionated plexi (superior left GP, inferior left GP, anterior right GP and inferior right GP). Ganglionated plexi (GP) were identified by delivering high-frequency stimulation (20 Hz) from the ablation catheter. If vagal response (AV block) was initiated by stimulation, that site was counted as a GP site and was then ablated. |
| 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 Tachyarrhythmia Recurrence in Participants | Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation. | all patients referred for paroxysmal AF ablation between 1-2004 and 12-2005 were included | Posted | Number | participants | 0-5 years |
|
The adverse effects were collected within the 1st year after ablation.
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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 | Experimental Arm (GP Ablation + PV Antrum Isolation) | All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| serious | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| groin hematoma | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sunny Po, MD., Study Principal Investigator | University of Oklahoma Health Sciences Center | 405-271-9696 | sunny-po@ouhsc.edu |
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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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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Total Number of Significant Ablation Procedure Related Complications | Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke. | Posted | Number | Complications | 0-1 year |
|
|
|
| 10 |
| 119 |
| 9 |
| 119 |
| pericardial effusion/tamponade | Cardiac disorders | Systematic Assessment |
|
| stroke | Nervous system disorders | Systematic Assessment |
|
| phrenic nerve injury | Nervous system disorders | Systematic Assessment |
|
| death | Gastrointestinal disorders | Systematic Assessment |
|
| pneumonia | Infections and infestations | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |