THERMOCOOL STSF Bi- Directional Navigation Catheter
DeviceTHERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.
NCT Number: NCT06144632
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Grandview Medical Center, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.
TRUPULSE Generator will be used to deliver PF/RF ablation.
Time frame: 7 days post-procedure
PAEs occurring within 7 days of an ablation which uses the BWI ablation system (including atrio-esophageal fistula and pulmonary vein stenosis occurring greater than 7 days of post ablation procedure) will be reported.
Time frame: Up to 274 days
The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic AF, AT, or AFL will be reported.
Time frame: From baseline to 12 months post ablation procedure
Quality of life will be assessed as measured by the total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire score. The score ranges from 0 to 100, with higher scores indicating better quality of life.
Biosense Webster, Inc.
Industry
Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Acronym: SMARTPULSE PAF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06676072
Arrhythmias, Cardiac, Atrial Arrhythmia
Scottsdale, Arizona, United States
View Trial DetailsNCT07720557
Arrhythmias, Cardiac, Atrial Arrhythmia
Beijing, Beijing Municipality, China
View Trial Details