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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Half-normal saline | Experimental | Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters |
|
| Normal saline | Active Comparator | Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Half Normal Saline 0.45% Infusion Solution Bag | Drug | Randomization to half normal saline |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken for termination of atrial flutter | intraprocedural | |
| Total radiofrequency ablation time and procedural time | intraprocedural |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
Multicentre study, patient data deidentified for post-enrolment analysis
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| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline 0.9% Infusion Solution Bag | Drug | Randomization to normal saline |
|
marker of excessive heating of the tissue |
| periprocedural |
| D013568 |
| Pathological Conditions, Signs and Symptoms |