An interventional study of Half-normal saline and Normal saline in Ventricular Arrythmia, sponsored by Texas Cardiac Arrhythmia Research Foundation. Suspended at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Texas Cardiac Arrhythmia Research Foundation · Not applicable, Interventional, and Other
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.
Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Half-normal saline
Drug: Normal saline
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Use of normal saline as an irrigant for open-irrigated ablation catheters
total radiofrequency ablation time, and total procedure time
Time frame: intraprocedural
acute success
elimination of the VAs, or \<10 morphologically similar PVCs during a 15-minute waiting period
Time frame: intraprocedural
long-term success
elimination of the VAs, or a reduction of \>75% of the PVC burden associated with marked improved in symptoms
Time frame: 1 year
procedure-related complications
pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, coronary artery injury, death
Time frame: periprocedural (at the time of the procedure and up to 1 month)
hyponatremia
serum sodium level \< 135 mEq/L
Time frame: periprocedural (at the time of the procedure and up to 1 month)
Started May 2018 (actual). Primary completion is estimated for Apr 2022, 47 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Texas Cardiac Arrhythmia Research Foundation