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

NCT ID: NCT03502499

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-16
• Study Completion Date: 2022-04-30

Brief 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.

Conditions

Ventricular Arrythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Half-normal saline

Group Type: EXPERIMENTAL

Half-normal saline

Intervention Type: DRUG

Use of half-normal saline as an irrigant for open-irrigated ablation catheters

Normal saline

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

Use of normal saline as an irrigant for open-irrigated ablation catheters

Interventions

Half-normal saline

Use of half-normal saline as an irrigant for open-irrigated ablation catheters

Intervention Type: DRUG

Normal saline

Use of normal saline as an irrigant for open-irrigated ablation catheters

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Andrea Natale

Executive Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Austin, Texas, United States

Countries

United States

Other Identifiers

TCAI_HNS_VA

Identifier Type: -

Identifier Source: org_study_id