To establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF).
The VISUALISE AF study is a multi-center (global), open label, prospective, single arm study to establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System. The planned indication for use within the United States for LUMINIZE RF Balloon Catheter System is for the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Ablation Therapy with the LUMINIZE RF Balloon Catheter
Safety event free rate at 12 months post procedure.
Primary safety events will consist of a composite of procedure-related and/or device-related adverse events.
Time frame: 0-12 months post procedure
Failure free rate at 12 months post procedure.
Failure defined as: * Failure to achieve acute procedural success * Use of amiodarone post index procedure * Surgical treatment for AF/ AFL/ AT post index procedure * Use of a non-study ablation catheter for any AF targets in the index procedure or repeat procedure during the blanking period * More than one repeat procedure with the LUMINIZE RF Balloon Catheter during the blanking period * Documented atrial fibrillation, or new onset of AFL or AT between days 91 post index procedure and 365 days post index procedure captured by one of the following methods: * ≥ 30 seconds in duration from the study specific event monitor or Holter Monitor * ≥ 10 seconds 12-lead Electrocardiography (ECG) * Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between days 91 post index procedure and 365 days: * Repeat procedure * Cardioversion for AF/AFL/AT * Prescribed any antiarrhythmic drug (AAD)\*
Time frame: 0-12 months post procedure
Secondary Safety Endpoint
Serious Adverse Events (SAE) and Adverse Events (AE) related to the procedure and/or study device through 12 months post Index Procedure.
Time frame: 12 months
Acute procedural success
Rate of acute procedural success defined as the achievement of electrical isolation of all pulmonary veins (PVs) by using the LUMINIZE RF Balloon Catheter system.
Time frame: 1 day
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