Half-normal Saline in Atrial Fibrillation Ablation

Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters 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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Half-normal saline; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Half-normal saline	Drug: Half-normal saline; Use of half-normal saline as an irrigant for open-irrigated ablation catheters
ACTIVE_COMPARATOR: Normal saline	Drug: Normal saline; Use of normal saline as an irrigant for open-irrigated ablation catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total radiofrequency ablation time, and total procedure time	intraprocedural
acute pulmonary veins, and left atrial appendage (if applicable) reconnection	intraprocedural
freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs	1 year
long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection	in case of a repeat procedure performed during the study follow-up (an average of 1 year)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hyponatremia	serum sodium level < 135 mEq/L	periprocedural (at the time of the procedure and up to 1 month)
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	periprocedural (at the time of the procedure and up to 1 month)

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Investigators: Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ACTUAL): May 2, 2019
• Study Completion (ACTUAL): May 2, 2020

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (ACTUAL): April 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TCAI_HNS_AF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No