An interventional study of Half-normal saline and Normal saline in Atrial Fibrillation, sponsored by Texas Cardiac Arrhythmia Research Foundation. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Texas Cardiac Arrhythmia Research Foundation · Not applicable, Interventional, and Other
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.
Exclusion criteria
Drug: Half-normal saline
Drug: Normal saline
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Use of normal saline as an irrigant for open-irrigated ablation catheters
total radiofrequency ablation time, and total procedure time
Time frame: intraprocedural
acute pulmonary veins, and left atrial appendage (if applicable) reconnection
Time frame: intraprocedural
freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs
Time frame: 1 year
freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs
Time frame: 1 year
long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection
Time frame: in case of a repeat procedure performed during the study follow-up (an average of 1 year)
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
Time frame: periprocedural (at the time of the procedure and up to 1 month)
hyponatremia
serum sodium level \< 135 mEq/L
Time frame: periprocedural (at the time of the procedure and up to 1 month)
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Texas Cardiac Arrhythmia Research Foundation