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OpenTrials
Completed

NCT Number: NCT04001530

Half-normal Saline in Atrial Flutter Ablation

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.

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Half Normal Saline 0.45% Infusion Solution Bag

Drug

Randomization to half normal saline

Normal Saline 0.9% Infusion Solution Bag

Drug

Randomization to normal saline

Primary outcomes

  1. Time taken to produce bidirectional block

    Time frame: intraprocedural

  2. Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block

    Time frame: intraprocedural

  3. Freedom from atrial flutter recurrence

    Time frame: 1 year

Secondary outcomes

  1. Time taken for termination of atrial flutter

    Time frame: intraprocedural

  2. Total radiofrequency ablation time and procedural time

    Time frame: intraprocedural

Other outcomes

  1. Incidence of procedure-related complications

    Time frame: 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

  2. Incidence of steam pops

    Time frame: periprocedural

    marker of excessive heating of the tissue

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2019
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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