Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation

Texas Cardiac Arrhythmia Research Foundation

Status

Suspended

Conditions

Ventricular Arrythmia

Treatments

Drug: Half-normal saline

Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03502499

TCAI_HNS_VA

Details and patient eligibility

About

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during left ventricular outflow tract ventricular arrhythmias 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

50 estimated 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 left ventricular outflow tract ventricular arrhythmias
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

ventricular arrhythmias originating from the right ventricular outflow tract according to the ventricular arrhythmia ECG morphology (i.e., precordial R wave transition at V3 or later)
ventricular arrhythmias not originating from cardiac outflow tracts
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