An interventional study of Half Normal Saline 0.45% Infusion Solution Bag and Normal Saline 0.9% Infusion Solution Bag in Atrial Flutter, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Other
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.
213 studies on the registry are indexed under Atrial Flutter; 50 are open to participants now.
This study's enrollment of 4 is below the median of 134 across 145 interventional studies indexed under Atrial Flutter.
Browse Atrial Flutter studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 half normal saline
Randomization to normal saline
Time taken to produce bidirectional block
Time frame: intraprocedural
Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block
Time frame: intraprocedural
Freedom from atrial flutter recurrence
Time frame: 1 year
Time taken for termination of atrial flutter
Time frame: intraprocedural
Total radiofrequency ablation time and procedural time
Time frame: intraprocedural
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
Time frame: at the time of the procedure and up to 1 month
Incidence of steam pops
marker of excessive heating of the tissue
Time frame: periprocedural
Plan to share: Undecided — Multicentre study, patient data deidentified for post-enrolment analysis
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre