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Completed

NCT Number: NCT03498586

Half-normal Saline in Atrial Fibrillation Ablation

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female between 18 and 75 years of age at the time of enrollment
  • undergoing first-time radiofrequency ablation for atrial fibrillation
  • written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

  • robotic-guided atrial fibrillation ablation
  • baseline hyponatremia (serum sodium level < 135 mEq/L)
  • pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  • presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Treatment and study plan

Half-normal saline

Drug

Use of half-normal saline as an irrigant for open-irrigated ablation catheters

normal saline

Drug

Use of normal saline as an irrigant for open-irrigated ablation catheters

Primary outcomes

  1. total radiofrequency ablation time, and total procedure time

    Time frame: intraprocedural

  2. acute pulmonary veins, and left atrial appendage (if applicable) reconnection

    Time frame: intraprocedural

  3. freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs

    Time frame: 1 year

Secondary outcomes

  1. freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs

    Time frame: 1 year

  2. long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection

    Time frame: in case of a repeat procedure performed during the study follow-up (an average of 1 year)

Other outcomes

  1. procedure-related complications

    Time frame: periprocedural (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. hyponatremia

    Time frame: periprocedural (at the time of the procedure and up to 1 month)

    serum sodium level < 135 mEq/L

Sponsors and collaborators

Lead sponsor

Texas Cardiac Arrhythmia Research Foundation

Other

Registry information

Official study title

Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 13, 2018
Registry last updated
Apr 5, 2022

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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