Half-normal Saline in Atrial Fibrillation Ablation

Texas Cardiac Arrhythmia Research Foundation

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Normal saline; Drug: Half-normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03498586

TCAI_HNS_AF

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 2 patient groups

Half-normal saline

Experimental group

Treatment:

Drug: Half-normal saline

Normal saline

Active Comparator group

Treatment:

Drug: Normal saline