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The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Half-normal saline | Experimental |
| |
| Normal saline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Half-normal saline | Drug | Use of half-normal saline as an irrigant for open-irrigated ablation catheters |
|
| Measure | Description | Time Frame |
|---|---|---|
| total radiofrequency ablation time, and total procedure time | intraprocedural | |
| acute pulmonary veins, and left atrial appendage (if applicable) reconnection | intraprocedural | |
| freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs | 1 year | |
| long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection | in case of a repeat procedure performed during the study follow-up (an average of 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| procedure-related complications | pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula, death | periprocedural (at the time of the procedure and up to 1 month) |
| hyponatremia |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | Texas Cardiac Arrhythmia Institute, St. David's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Institute, St. David's Medical Center | Austin | Texas | 78705 | United States | ||
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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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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | Use of normal saline as an irrigant for open-irrigated ablation catheters |
|
serum sodium level < 135 mEq/L |
| periprocedural (at the time of the procedure and up to 1 month) |
| Sunnybrook Health Sciences Centre |
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |