Ventricular Arrythmia
Conditions
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.
Interventions
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
DRUGNormal saline
Use of normal saline as an irrigant for open-irrigated ablation catheters
Sponsors
Texas Cardiac Arrhythmia Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed