Atrial Flutter
Conditions
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.
Interventions
DRUGHalf Normal Saline 0.45% Infusion Solution Bag
Randomization to half normal saline
Randomization to normal saline
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block | intraprocedural |
| Time taken to produce bidirectional block | intraprocedural |
| Freedom from atrial flutter recurrence | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Total radiofrequency ablation time and procedural time | intraprocedural |
| Time taken for termination of atrial flutter | intraprocedural |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of procedure-related complications | at the time of the procedure and up to 1 month | pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula, death |
| Incidence of steam pops | periprocedural | marker of excessive heating of the tissue |
Countries
Canada
Outcome results
None listed