Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
DRUGNormal saline
Use of normal saline as an irrigant for open-irrigated ablation catheters
Sponsors
Texas Cardiac Arrhythmia Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* male or female between 18 and 75 years of age at the time of enrollment * undergoing first-time radiofrequency ablation for atrial fibrillation * written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Exclusion criteria
* robotic-guided atrial fibrillation ablation * baseline hyponatremia (serum sodium level \< 135 mEq/L) * pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| acute pulmonary veins, and left atrial appendage (if applicable) reconnection | intraprocedural |
| total radiofrequency ablation time, and total procedure time | intraprocedural |
| freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs | 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| procedure-related complications | periprocedural (at the time of the procedure and up to 1 month) | pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula, death |
| hyponatremia | periprocedural (at the time of the procedure and up to 1 month) | serum sodium level \< 135 mEq/L |
Countries
Canada, United States
Outcome results
None listed