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

T

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Half-normal saline
Experimental group
Treatment:
Drug: Half-normal saline
Normal saline
Active Comparator group
Treatment:
Drug: Normal saline

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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