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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Drug: Half Normal Saline 0.45% Infusion Solution Bag; Drug: Normal Saline 0.9% Infusion Solution Bag

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Half-normal saline; Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters	Drug: Half Normal Saline 0.45% Infusion Solution Bag; Randomization to half normal saline
Active Comparator: Normal saline; Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters	Drug: Normal Saline 0.9% Infusion Solution Bag; Randomization to normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Time taken for termination of atrial flutter	intraprocedural
Total radiofrequency ablation time and procedural time	intraprocedural

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 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	at the time of the procedure and up to 1 month
Incidence of steam pops	marker of excessive heating of the tissue	periprocedural

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter; Pharmaceutical Solutions
• Other Study ID Numbers: 156-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Multicentre study, patient data deidentified for post-enrolment analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No