Half-normal Saline in Atrial Flutter Ablation
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Half Normal Saline 0.45% Infusion Solution Bag
Normal Saline 0.9% Infusion Solution Bag
Sponsored by
About this trial
This is an interventional other trial for Atrial Flutter
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Half-normal saline
Normal saline
Arm Description
Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters
Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters
Outcomes
Primary Outcome Measures
Time taken to produce bidirectional block
Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block
Freedom from atrial flutter recurrence
Secondary Outcome Measures
Time taken for termination of atrial flutter
Total radiofrequency ablation time and procedural time
Full Information
NCT ID
NCT04001530
First Posted
June 26, 2019
Last Updated
July 2, 2021
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04001530
Brief Title
Half-normal Saline in Atrial Flutter Ablation
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Half-normal saline
Arm Type
Experimental
Arm Description
Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters
Arm Title
Normal saline
Arm Type
Active Comparator
Arm Description
Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters
Intervention Type
Drug
Intervention Name(s)
Half Normal Saline 0.45% Infusion Solution Bag
Intervention Description
Randomization to half normal saline
Intervention Type
Drug
Intervention Name(s)
Normal Saline 0.9% Infusion Solution Bag
Intervention Description
Randomization to normal saline
Primary Outcome Measure Information:
Title
Time taken to produce bidirectional block
Time Frame
intraprocedural
Title
Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block
Time Frame
intraprocedural
Title
Freedom from atrial flutter recurrence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time taken for termination of atrial flutter
Time Frame
intraprocedural
Title
Total radiofrequency ablation time and procedural time
Time Frame
intraprocedural
Other Pre-specified Outcome Measures:
Title
Incidence of procedure-related complications
Description
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
Title
Incidence of steam pops
Description
marker of excessive heating of the tissue
Time Frame
periprocedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Multicentre study, patient data deidentified for post-enrolment analysis
Learn more about this trial
Half-normal Saline in Atrial Flutter Ablation
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