Half-normal Saline in Atrial Flutter Ablation

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001530
• Other study ID #: 156-2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Drug:
• Half Normal Saline 0.45% Infusion Solution Bag
Randomization to half normal saline
• Normal Saline 0.9% Infusion Solution Bag
Randomization to normal saline

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Incidence of steam pops	marker of excessive heating of the tissue	periprocedural
Primary	Time taken to produce bidirectional block		intraprocedural
Primary	Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block		intraprocedural
Primary	Freedom from atrial flutter recurrence		1 year
Secondary	Time taken for termination of atrial flutter		intraprocedural
Secondary	Total radiofrequency ablation time and procedural time		intraprocedural