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

Not Applicable

Suspended

• Conditions: Ventricular Arrythmia
• Interventions: Drug: Half-normal saline; Drug: Normal saline

• Registration Number: NCT03502499
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Study Start: 2018-05-16
• Status Verified: 2022-04
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Half-normal saline	Half-normal saline	-
Normal saline	Normal saline	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Texas Cardiac Arrhythmia Institute, St. David's Medical Center; 🇺🇸 Austin, Texas, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States