An interventional study of Half-normal saline and Normal saline in Atrial Fibrillation, sponsored by Texas Cardiac Arrhythmia Research Foundation. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-05.
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 atrial fibrillation 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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 99 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
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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.
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.
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 pulmonary veins, and left atrial appendage (if applicable) reconnection
Time frame: intraprocedural
freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs
Time frame: 1 year
freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs
Time frame: 1 year
long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection
Time frame: in case of a repeat procedure performed during the study follow-up (an average of 1 year)
procedure-related complications
pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula, 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)
This study is completed, 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