Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2018-05-02
2020-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Half-normal saline
Half-normal saline
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Normal saline
Normal saline
Use of normal saline as an irrigant for open-irrigated ablation catheters
Interventions
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Half-normal saline
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Normal saline
Use of normal saline as an irrigant for open-irrigated ablation catheters
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Texas Cardiac Arrhythmia Research Foundation
OTHER
Responsible Party
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Andrea Natale
Executive Medical Director
Principal Investigators
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Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Locations
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Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin, Texas, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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TCAI_HNS_AF
Identifier Type: -
Identifier Source: org_study_id
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