NCT04001530

Half-normal Saline in Atrial Flutter Ablation

Verification of Half Normal Saline as a Superior Irrigant in the Catheter Radiofrequency Ablation of Typical Cavotricuspid Isthmus Dependent Atrial Flutter: A Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter.

Detailed description

It is unclear whether ionic strength affects energy delivery and ablation lesion size during radiofrequency ablation for atrial flutter. Given that saline contains ionic sodium and chloride in the solution, it has conductive properties that may disperse radiofrequency energy away from the tip-tissue interface, thereby reducing current density and lesion size compared to ablation with nonionic solutions. The efficacy of half-normal saline will be measured by the time taken to create bidirectional block across the cavotricuspid isthmus as well as the acute recurrence rate within 30 minutes of the initial occurrence of bidirectional block and the 1 year freedom from flutter recurrence.

Conditions

• Atrial Flutter

Interventions

Type	Name	Description
DRUG	Half Normal Saline 0.45% Infusion Solution Bag	Randomization to half normal saline
DRUG	Normal Saline 0.9% Infusion Solution Bag	Randomization to normal saline

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2019-06-28
• Last updated: 2021-07-06

Locations

1 site across 1 country: Canada