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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03502499
Other study ID # TCAI_HNS_VA
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date May 16, 2018
Est. completion date April 2022

Study information

Verified date April 2022
Source Texas Cardiac Arrhythmia Research Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 50
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other procedure-related complications pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, coronary artery injury, death periprocedural (at the time of the procedure and up to 1 month)
Other hyponatremia serum sodium level < 135 mEq/L periprocedural (at the time of the procedure and up to 1 month)
Primary total radiofrequency ablation time, and total procedure time intraprocedural
Primary acute success elimination of the VAs, or <10 morphologically similar PVCs during a 15-minute waiting period intraprocedural
Primary long-term success elimination of the VAs, or a reduction of >75% of the PVC burden associated with marked improved in symptoms 1 year
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