Half-normal Saline in Atrial Flutter Ablation

Not Applicable

Completed

• Conditions: Atrial Flutter
• Interventions: Drug: Half Normal Saline 0.45% Infusion Solution Bag; Drug: Normal Saline 0.9% Infusion Solution Bag

• Registration Number: NCT04001530
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Patients > 18 years of age at the time of enrollment
• Patients presenting for right sided typical atrial flutter ablation who have a clinical indication to undergo catheter ablation
• Fully informed written informed consent by either the subject or subject's legal representative and ability for subject to comply with study responsibilities

Exclusion Criteria

• The presence of thrombus within the left atrial appendage
• Prior catheter ablation of the cavotricuspid isthmus for right sided atrial flutter
• The inability to provide consent or comply with study requirements
• A predicted life expectancy of < 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Half-normal saline	Half Normal Saline 0.45% Infusion Solution Bag	Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters
Normal saline	Normal Saline 0.9% Infusion Solution Bag	Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters

Primary Outcome Measures

Name	Time	Method
Time taken to produce bidirectional block	intraprocedural
Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block	intraprocedural
Freedom from atrial flutter recurrence	1 year

Secondary Outcome Measures

Name	Time	Method
Time taken for termination of atrial flutter	intraprocedural
Total radiofrequency ablation time and procedural time	intraprocedural

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada