Half-normal Saline in Atrial Flutter Ablation

Study Overview
=================
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.

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

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Drug: Half Normal Saline 0.45% Infusion Solution Bag
* Drug: Normal Saline 0.9% Infusion Solution Bag


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Half-normal saline<br>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<br>* Randomization to half normal saline<br>|
| Active Comparator: Normal saline<br>Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters | Drug: Normal Saline 0.9% Infusion Solution Bag<br>* Randomization to normal saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken for termination of atrial flutter |  | intraprocedural | 
| Total radiofrequency ablation time and procedural time |  | intraprocedural |