Half-normal Saline in Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498586
• Other study ID #: TCAI_HNS_AF
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: May 2, 2020

Study information

• Verified date: April 2022
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2, 2020
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Half-normal saline
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
• Normal saline
Use of normal saline as an irrigant for open-irrigated ablation catheters

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	Texas Cardiac Arrhythmia Institute, St. David's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	hyponatremia	serum sodium level < 135 mEq/L	periprocedural (at the time of the procedure and up to 1 month)
Primary	total radiofrequency ablation time, and total procedure time		intraprocedural
Primary	acute pulmonary veins, and left atrial appendage (if applicable) reconnection		intraprocedural
Primary	freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs		1 year
Secondary	freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs		1 year
Secondary	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)