Status:
WITHDRAWN
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when ...
Eligibility Criteria
Inclusion
- Diagnosed with symptomatic Paroxysmal Atrial Fibrillation (PAF) defined as AF that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
- Selected for AF ablation procedure by pulmonary vein isolation (PVI)
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion
- Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \[body mass index more than {\>} 40 kilogram per square meter {kg/m\^2}\], renal insufficiency \[with an estimated creatinine clearance less than {\<}30 milliliter {mL}/minute {min}/1.73 meter {m}\^2\])
- Previous left atrium (LA) ablation or surgery
- Participants known to require ablation outside the pulmonary vein (PV) region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
- Previously diagnosed with persistent AF (\>7 days in duration)
- Severe dilatation of the LA (left anterior descending artery \[LAD\] \>50 millimetre \[mm\] antero-posterior diameter or left atrium volume index \[LAVi\] \>48 \[mL/m\^2\] in case of transthoracic echocardiography \[TTE\])
Key Trial Info
Start Date :
August 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06495216
Start Date
August 17 2024
End Date
December 26 2025
Last Update
February 4 2025
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