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

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

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.

Study Overview

• Status: Suspended
• Conditions: Ventricular Arrythmia
• Intervention / Treatment: Drug: Half-normal saline; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Half-normal saline	Drug: Half-normal saline; Use of half-normal saline as an irrigant for open-irrigated ablation catheters
ACTIVE_COMPARATOR: Normal saline	Drug: Normal saline; Use of normal saline as an irrigant for open-irrigated ablation catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total radiofrequency ablation time, and total procedure time		intraprocedural
acute success	elimination of the VAs, or <10 morphologically similar PVCs during a 15-minute waiting period	intraprocedural
long-term success	elimination of the VAs, or a reduction of >75% of the PVC burden associated with marked improved in symptoms	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
hyponatremia	serum sodium level < 135 mEq/L	periprocedural (at the time of the procedure and up to 1 month)

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Investigators: Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2018
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: TCAI_HNS_VA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No