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

NCT03502499 — Not applicable, Suspended, 50 participants, Texas Cardiac Arrhythmia Research Foundation

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

Registry	NCT03502499
Status	Suspended - slow enrollment
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	50 (Estimated)
Sponsor	Texas Cardiac Arrhythmia Research Foundation (Other)
Conditions	Ventricular Arrythmia
Interventions	Half-normal saline, Normal saline (Drug)
Dates	start 2018-05-16, primary completion 2022-04-01 (estimated), completion 2022-04-01 (estimated), first posted 2018-04-18, last updated 2022-04-11
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Half-normal saline	Experimental	Drug: Half-normal saline
Normal saline	Active comparator	Drug: Normal saline

Half-normal saline (Drug): Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Normal saline (Drug): Use of normal saline as an irrigant for open-irrigated ablation catheters

+Outcome measures

Primary outcomes

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

Other outcomes

procedure-related complications [periprocedural (at the time of the procedure and up to 1 month)]: pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, coronary artery injury, death
hyponatremia [periprocedural (at the time of the procedure and up to 1 month)]: serum sodium level < 135 mEq/L

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (2)

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

+Investigators

Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Institute, St. David's Medical Center