SuspendedNot Applicable

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

Stopped: slow enrollment

United States50 participantsStarted 2018-05-16

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

total radiofrequency ablation time, and total procedure time

Timeframe: intraprocedural

acute success

Timeframe: intraprocedural

long-term success

Timeframe: 1 year

Trial details

NCT IDNCT03502499

SponsorTexas Cardiac Arrhythmia Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04

View on ClinicalTrials.gov More Ventricular Arrythmia trials