Half-normal Saline in Atrial Fibrillation Ablation

Sponsor

Texas Cardiac Arrhythmia Research Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT03498586

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

49.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Half-normal saline Drug: Normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 2, 2018

Actual Primary Completion Date :

May 2, 2019

Actual Study Completion Date :

May 2, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

procedure-related complications [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
hyponatremia [periprocedural (at the time of the procedure and up to 1 month)]
serum sodium level < 135 mEq/L

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Cardiac Arrhythmia Institute, St. David's Medical Center	Austin	Texas	United States	78705
2	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

Texas Cardiac Arrhythmia Research Foundation

Investigators

Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation

ClinicalTrials.gov Identifier:

NCT03498586

Other Study ID Numbers:

TCAI_HNS_AF

First Posted:

Apr 13, 2018

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Apr 5, 2022