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

Ventricular Arrythmia Clinical Trial

Official title:

Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03502499
• Other study ID #: TCAI_HNS_VA
• Status: Suspended
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: April 2022

Study information

• Verified date: April 2022
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrythmia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Texas Cardiac Arrhythmia Institute, St. David's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	procedure-related complications	pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, coronary artery injury, death	periprocedural (at the time of the procedure and up to 1 month)
Other	hyponatremia	serum sodium level < 135 mEq/L	periprocedural (at the time of the procedure and up to 1 month)
Primary	total radiofrequency ablation time, and total procedure time		intraprocedural
Primary	acute success	elimination of the VAs, or <10 morphologically similar PVCs during a 15-minute waiting period	intraprocedural
Primary	long-term success	elimination of the VAs, or a reduction of >75% of the PVC burden associated with marked improved in symptoms	1 year