Half-normal Saline in Atrial Flutter Ablation

NCT ID: NCT04001530

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-01-31

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.

Conditions

Atrial Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Half-normal saline

Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters

Group Type: EXPERIMENTAL

Half Normal Saline 0.45% Infusion Solution Bag

Intervention Type: DRUG

Randomization to half normal saline

Normal saline

Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters

Group Type: ACTIVE_COMPARATOR

Normal Saline 0.9% Infusion Solution Bag

Intervention Type: DRUG

Randomization to normal saline

Interventions

Half Normal Saline 0.45% Infusion Solution Bag

Randomization to half normal saline

Intervention Type: DRUG

Normal Saline 0.9% Infusion Solution Bag

Randomization to normal saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Benedict Glover

Staff electrophysiologist Schulich Heart Program, Associate Professor University of Toronto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

156-2019

Identifier Type: -

Identifier Source: org_study_id